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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83265

134 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 02, 2019
Product types
Drug
Classifications
Class II
Statuses
Completed
Recalling firm wording
Altaire Pharmaceuticals, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

134 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 134

Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35

D-0352-2020
Recall number
D-0352-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
1737549 containers

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: RGC, Exp 7/19; RHB, RHC, Exp 8/19; RID, RIC, RIG, Exp 9/19; RKH, RKI, RKJ, RKK, RKL, Exp 11/19; RLM, Exp 12/19; SAI, Exp 1/20; SBG, SBH, Exp 2/20; SCF, Exp 3/20, SEA, Exp 5/20; SFA, SFB, Exp 6/20; SHA, Exp 8/20; SIB, Exp 9/20; SJC, Exp 10/20; TAB, TAF, Exp 1/21; TBP, TBQ, Exp 2/21; TCV, TCW, Exp 3/21

Distribution pattern

U.S.A. Nationwide

drug · product 2 of 134

Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment Net Wt. 3.5 g, Rx only, Manufactured for Perrigo Minneapolis, MN 55427 NDC 0574-4250-35

D-0353-2020
Recall number
D-0353-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
121572 containers

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: SAC, Exp 1/20; SLK, Exp 12/20

Distribution pattern

U.S.A. Nationwide

drug · product 3 of 134

Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic Ointment USP, Net Wt. 3.5 g (1/8 oz), Rx only, Mfd. For Perrigo Minneapolis, MN 55427, NDC 0574-4144-35

D-0354-2020
Recall number
D-0354-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
87922 containers

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: SEE, SEG, Exp 5/20; SIE, Exp 9/20; SKD, Exp 11/20

Distribution pattern

U.S.A. Nationwide

drug · product 4 of 134

Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only, Manufactured for Perrigo, Minneapolis, MN 55427, NDC 0574-4021-35

D-0355-2020
Recall number
D-0355-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
261,528 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot#: RGD, Exp 7/19; RHL, Exp 8/19; RHB, Exp 9/19; RJF, Exp 10/19; RJG, Exp 10/19; SAJ, Exp 1/20; SAK, Exp 1/20; SAL, Exp 1/20; SAM, Exp 1/20; SBK, Exp 2/20; SEH, Exp 5/20; TCD, Exp 1/21

Distribution pattern

U.S.A. Nationwide

drug · product 5 of 134

Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35

D-0356-2020
Recall number
D-0356-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
651528 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: RGA 7/19 7/31/2017; RGE 7/19 8/11/2017; RGG7/19 8/11/2017; RGH 7/19 8/17/2017; RHM 8/19 9/14/2017; RJB 10/19 10/23/2017; RJA 10/19 10/23/2017; SCA 3/20 3/22/2018; SIC 9/20 10/9/2018; TAP 1/21 2/26/2019; TDE 4/21 5/30/2019

Distribution pattern

U.S.A. Nationwide

drug · product 6 of 134

Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4190-35

D-0357-2020
Recall number
D-0357-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
41148 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: RJD, Exp 10/19; SHG, Exp 8/20

Distribution pattern

U.S.A. Nationwide

drug · product 7 of 134

Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g (NDC 0574-4025-11) and Net Wt. 3.5 g (1/8 oz.) (NDC 0574-4025-35), Manufactured for Perrigo, Minneapolis, MN 55427

D-0358-2020
Recall number
D-0358-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
195,864 unts

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: RJH, Exp 10/19; SCC, Exp 3/21; SGA, Exp 7/21; SGH, Exp 7/21; SHH, Exp 8/21; SLL, Exp 12/21; TAC, Exp 1/22

Distribution pattern

U.S.A. Nationwide

drug · product 8 of 134

Lubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubricant), 0.5 oz. (15 mL), Distributed by: Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, Item #801483

D-0359-2020
Recall number
D-0359-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
35,896 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 19095, Exp 04/21

Distribution pattern

U.S.A. Nationwide

drug · product 9 of 134

Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477, Package Size: 2 x 15 mL, NDC 0363-0185-49

D-0360-2020
Recall number
D-0360-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 19095, Exp 04/21

Distribution pattern

U.S.A. Nationwide

drug · product 10 of 134

Walgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Sterile, Net Wt. 0.125 oz (3.5 g), Distributed by Walgreen Co. 200 Wilmot Road Deerfield, IL 60015, NDC 0363-7500-50

D-0361-2020
Recall number
D-0361-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
30240 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: TCI , Exp 03/21

Distribution pattern

U.S.A. Nationwide

drug · product 11 of 134

Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15 mL), Distributed by : Walgreen Co 200 Wilmot Road Deerfield IL 60015 NDC 0363-0193-13

D-0362-2020
Recall number
D-0362-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
43008 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 19105, Exp 04/22; 19050, Exp 02/22

Distribution pattern

U.S.A. Nationwide

drug · product 12 of 134

Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye Lubricant, Net Wt. 0.125 oz. (3.5g), Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Item #801486, NDC 0363-0191-50

D-0363-2020
Recall number
D-0363-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
45672 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: TDB, Exp 4/22

Distribution pattern

U.S.A. Nationwide

drug · product 13 of 134

Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-189-49

D-0364-2020
Recall number
D-0364-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
557,376 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17196, Exp 07/19; 17292, Exp 09/19; 17355, Exp 11/19; 19040, Exp 02/21

Distribution pattern

U.S.A. Nationwide

drug · product 14 of 134

Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-875-50

D-0365-2020
Recall number
D-0365-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
441792 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: SAJ, Exp 01/21; SFE, Exp 06/21; SIA, Exp 09/21; RIE, Exp 09/20; REH, Exp 05/20; RAD, Exp 01/20; TAH, Exp 01/22; TDD, Exp 04/22

Distribution pattern

U.S.A. Nationwide

drug · product 15 of 134

Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-197-49

D-0366-2020
Recall number
D-0366-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
469128 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17384, Exp 12/19; 17259, Exp 08/19; 19002, Exp 01/21; 19041, Exp 02/21; 18222, Exp 09/20; 18084, Exp 04/20

Distribution pattern

U.S.A. Nationwide

drug · product 16 of 134

Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g), Distributed by: Walmart Stores Inc., Bentonville, AR 72716, W-M item #551282425, NDC 49035-191-50

D-0367-2020
Recall number
D-0367-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
1537130 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: SKG,Exp 08/21; SHK, Exp 08/21; SHJ, Exp 08/21; SEC, Exp 05/21; SCB, Exp 03/21; SBC, Exp 02/21; RLB, Exp 12/20; RBB, Exp 02/20; RHR, Exp 08/20; RFK, Exp 06/20; RAB, Exp 01/20; TAD, Exp 01/22; TAQ, Exp 01/22; TBI, Exp 02/22; TDB, Exp 04/22; QHE, Exp 08/19; QJD, Exp 10/19; SGE, Exp 07/21

Distribution pattern

U.S.A. Nationwide

drug · product 17 of 134

Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000, Package Size: 3.5g and 15mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-883-59

D-0368-2020
Recall number
D-0368-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
55772 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: KT19146 02/21 06/05/2019 KT18133 04/20 12/12/2018 KT18194 07/20 01/15/2019 KT18129 02/20

Distribution pattern

U.S.A. Nationwide

drug · product 18 of 134

Equate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 15 mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-885-49

D-0369-2020
Recall number
D-0369-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
259104 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 19137 05/22 19022 01/22

Distribution pattern

U.S.A. Nationwide

drug · product 19 of 134

Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25 Single-Use Containers, 0.02 Fl. oz. (0.6 mL), W-M item #: 563031654, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54

D-0370-2020
Recall number
D-0370-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
99420 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: RKP 11/19 RIN 09/19 SLC 12/20 RIF 09/19 TBE 02/21 TBI 02/21 SHB 08/20

Distribution pattern

U.S.A. Nationwide

drug · product 20 of 134

Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M Item # 563031654, Package Size 7.5 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54

D-0371-2020
Recall number
D-0371-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
50,904 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17290; Exp 09/19

Distribution pattern

U.S.A. Nationwide

drug · product 21 of 134

Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-145-10 (Note: Support Harmony packaging was discontinued in January 2018.)

D-0372-2020
Recall number
D-0372-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
17,613 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17290, Exp 09/19; 19011, Exp 01/21; 18052, Exp 02/20; 18266, Exp 10/20; 18178, Exp07/20; 17385, Exp 12/19

Distribution pattern

U.S.A. Nationwide

drug · product 22 of 134

CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution, Sterile, 0.02 Fl. oz., (0.6 mL) each, 32 Single Use Vials, Item #538397, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895

D-0373-2020
Recall number
D-0373-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
152,369 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: SEI 5/21 SGC 7/21 QGB 07/19 QID 09/19 RJC 10/20 RCJ 03/20 RCB 03/20 TCJ 03/22

Distribution pattern

U.S.A. Nationwide

drug · product 23 of 134

CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #317916, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895

D-0374-2020
Recall number
D-0374-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
365,832 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17196 08/19 17192 09/19 17355 11/19 18024 01/20 18036 02/20 18237 09/20 18293 12/20 18105 04/20 18179 07/20 19040 2/21

Distribution pattern

U.S.A. Nationwide

drug · product 24 of 134

CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Item #247887

D-0375-2020
Recall number
D-0375-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
100,680 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17222 07/19 17386 12/19 19018 01/21 18016 01/20 18181 07/20 18104 04/20 19018 1/21

Distribution pattern

U.S.A. Nationwide

drug · product 25 of 134

CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895

D-0376-2020
Recall number
D-0376-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
531,936 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17215 07/19 17239 08/19 18081 03/21 18207 08/20 18274 11/21

Distribution pattern

U.S.A. Nationwide

drug · product 26 of 134

CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), Item #457802, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0377-2020
Recall number
D-0377-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
101,712 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17277 09/19 18006 01/20 18098 04/21 18006 1/20 19057 02/22

Distribution pattern

U.S.A. Nationwide

drug · product 27 of 134

CVS Health Preservative Free Lubricant Eye Drops (Carboxymethycellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, Item #495334, 60 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 31010 6

D-0378-2020
Recall number
D-0378-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
45,864 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: RGF 07/19 RHN 08/19 RIH 09/19 RJP 10/19 RKN 11/19 SDC 04/20 SFC 06/20 SFJ 06/20 SGI 07/20

Distribution pattern

U.S.A. Nationwide

drug · product 28 of 134

CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #994883, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39945 3

D-0379-2020
Recall number
D-0379-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
114,504 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: RGF 07/19 RHN 08/19 RIH 09/19 RJP 10/19 RKN 11/19 SDC 04/20 SFC 06/20 SFJ 06/20 SGI 07/20 SKF 11/20 TAE 01/21

Distribution pattern

U.S.A. Nationwide

drug · product 29 of 134

CVS Health Dry Eye Relief Lubricant Eye Drops, 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI 0805 Made in the USA 02895

D-0380-2020
Recall number
D-0380-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
39,288 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17215 07/19 17239 08/19 18081 03/21 18207 08/20 18274 11/21

Distribution pattern

U.S.A. Nationwide

drug · product 30 of 134

CVS Health Dry Eye Relief Lubricant Eye Drops, 1 FL OZ (30 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI 02895 Made in the USA

D-0381-2020
Recall number
D-0381-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
101712 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17277 09/19 18006 01/20 18098 04/21 18006 1/20 19057 02/22

Distribution pattern

U.S.A. Nationwide

drug · product 31 of 134

CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Item#: 495334,Product Size: 0.6 mL x 60 count, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0382-2020
Recall number
D-0382-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
45864 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: RGF, Exp 07/19; RHN, Exp 08/19; RIH, Exp 09/19; RJP, Exp 10/19; RKN, Exp 11/19; SDC Exp 04/20; SFC, Exp 06/20; SFJ, Exp 06/20; SGI, Exp 07/20

Distribution pattern

U.S.A. Nationwide

drug · product 32 of 134

CVS Health Preservative Free Lubricant Eye Drops, 60 Sterile Single-Use Containers, 0.02 FL OZ (0.6 mL) EACH, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0383-2020
Recall number
D-0383-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
39072 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: RGF 07/19 RHN 08/19 RIH 09/19 RJP 10/19 RKN 11/19 SDC 04/20 SFC 06/20 SFJ 06/20 SGI 07/20 SKF 11/20 TAE 01/21

Distribution pattern

U.S.A. Nationwide

drug · product 33 of 134

CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item #881532, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0384-2020
Recall number
D-0384-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
284,232 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: RJK 10/19 SBJ 2/20 SFG 6/20 SHI 8/20 SLB 12/20 TCM 03/21 TDC 4/21

Distribution pattern

U.S.A. Nationwide

drug · product 34 of 134

CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #247781, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0385-2020
Recall number
D-0385-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: SAS 1/21 SIA 9/21 SFE 6/21 SAS 1/21 SFE 6/21 SIA 9/21 RIE 9/20 REH 5/20 RAD 1/20 TAH 1/22

Distribution pattern

U.S.A. Nationwide

drug · product 35 of 134

CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium 1%, Dry Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Item #799143, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0386-2020
Recall number
D-0386-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
159,864 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 19087 3/21 17289 9/19 19087 03/21 18122 5/20

Distribution pattern

U.S.A. Nationwide

drug · product 36 of 134

CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (15 mL), Item #895160, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0387-2020
Recall number
D-0387-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
238,968 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17223 07/19 17297 10/19 18017 01/20 18018 01/20 18065 03/21 18213 08/20 18247 10/21

Distribution pattern

U.S.A. Nationwide

drug · product 37 of 134

CVS Health Preservative Free Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item #994881 Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0388-2020
Recall number
D-0388-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
39,744 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17296 10/19 18094 04/20 18206 08/20

Distribution pattern

U.S.A. Nationwide

drug · product 38 of 134

CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0389-2020
Recall number
D-0389-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
77,760 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: QHI 08/19 QJG 10/19 RBA 02/20 RCF 03/20 RCM 03/20 RDJ 04/20 RFA 06/20 RHI 08/20 RJI 10/20 RKG 11/20 SBF 2/21 SDD 04/21

Distribution pattern

U.S.A. Nationwide

drug · product 39 of 134

CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5%, Sensitive Solution, 70 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #457791, NDC 50428 41429 3, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0390-2020
Recall number
D-0390-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
109,020 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: QHF 08/19 QHI 08/19 QLA 12/19 RBA 02/20 RCF 03/20 RCM 03/20 RDJ 04/20 RFA 06/20 RHI 08/20 RJI 10/20 RKG 11/20 RLE 12/20 SAW 01/21 SBF 02/21

Distribution pattern

U.S.A. Nationwide

drug · product 40 of 134

CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5% Glycerin 1% Polysorbate 80 0.5%), Advanced Relief, 30 Sterile Single-Use Containers 0.02 fl. oz. (0.6 mL) each, Item #563442, NDC 50428 30295 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0391-2020
Recall number
D-0391-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
48,168 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: RJM 10/19 RIA 09/19 SAN 01/20 SFF 06/20

Distribution pattern

U.S.A. Nationwide

drug · product 41 of 134

CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0392-2020
Recall number
D-0392-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
483528 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17251 8/19 17269 9/19 17360 12/19 18012 1/20 18106 4/20 18275 11/20 18275 11/20

Distribution pattern

U.S.A. Nationwide

drug · product 42 of 134

CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #317912, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0393-2020
Recall number
D-0393-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
464424 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 18229 9/21 18031 1/21 17131 5/20 17059 3/20 17008 1/20 19056 03/22

Distribution pattern

U.S.A. Nationwide

drug · product 43 of 134

CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0394-2020
Recall number
D-0394-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 18229 9/21 18229 9/21 19056 03/22

Distribution pattern

U.S.A. Nationwide

drug · product 44 of 134

CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0395-2020
Recall number
D-0395-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: QHE, Exp 08/19; QJD, Exp 10/19

Distribution pattern

U.S.A. Nationwide

drug · product 45 of 134

CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0396-2020
Recall number
D-0396-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
222096 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

18043 2/20 18115 5/20 18300 12/20 18300 12/20 18116 5/20 18115 5/20 18044 2/20 18043 2/20

Distribution pattern

U.S.A. Nationwide

drug · product 46 of 134

Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-503-15

D-0397-2020
Recall number
D-0397-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

16260 9/19 17303 10/20 18032 2/21 18235 9/21 18285 11/21 19021 1/22

Distribution pattern

U.S.A. Nationwide

drug · product 47 of 134

Ocusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-904-15

D-0398-2020
Recall number
D-0398-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
139572 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

16250 09/19 16268 10/19 16301 11/19 17088 3/20 17109 4/20 17318 10/20 17323 10/20 18014 1/21 18045 2/21 18059 3/21 18063 3/21 18117 5/21 18134 5/21

Distribution pattern

U.S.A. Nationwide

drug · product 48 of 134

Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-874-13

D-0399-2020
Recall number
D-0399-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
2,042,136 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

19128 05/21 19009 01/21 19003 01/21 19034 01/21 19060 02/21 19061 02/21 18252 10/20 18058 03/20 18224 09/20 18185 07/20 18152 06/20 18159 06/20 18091 04/20 18090 04/20 18069 03/20

Distribution pattern

U.S.A. Nationwide

drug · product 49 of 134

CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0401-2020
Recall number
D-0401-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17238 08/19 18094 4/20 19058 02/21

Distribution pattern

U.S.A. Nationwide

drug · product 50 of 134

CVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0402-2020
Recall number
D-0402-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
159864 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

19087 3/21 17289 9/19 19087 03/21 18122 5/20

Distribution pattern

U.S.A. Nationwide

drug · product 51 of 134

CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0403-2020
Recall number
D-0403-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
39,744 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17296 10/19 18094 04/20 18206 08/20

Distribution pattern

U.S.A. Nationwide

drug · product 52 of 134

CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0404-2020
Recall number
D-0404-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
48,168 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17285 09/19 18067 03/20 18205 08/20 18067 3/20

Distribution pattern

U.S.A. Nationwide

drug · product 53 of 134

CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, Product Size: 0.6 mL x 24 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0405-2020
Recall number
D-0405-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
58,704 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

RIN 09/19 RKP 11/19 SAR 01/20 SCG 03/20 SED 5/20 SLC 12/20 TBE 02/21 TBL 02/21

Distribution pattern

U.S.A. Nationwide

drug · product 54 of 134

CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item#: 258625 Product Size: 0.6 mL x 60 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0406-2020
Recall number
D-0406-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
39,072 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

RHD 08/19 RIF 09/19 RIN 09/19 RKP 11/19 SAR 01/20 SCG 03/20 SED 5/20

Distribution pattern

U.S.A. Nationwide

drug · product 55 of 134

CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief, Sterile, 0.33 fl. oz. (10 mL), Item #968210, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0407-2020
Recall number
D-0407-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
66,159 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17291 9/19 17385 12/19 18118 5/20 18266 10/20

Distribution pattern

U.S.A. Nationwide

drug · product 56 of 134

CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack, Item#: 495323, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0409-2020
Recall number
D-0409-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
37656 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17291 9/19 17385 12/19 18118 5/20

Distribution pattern

U.S.A. Nationwide

drug · product 57 of 134

CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz., (15 mL), Item #994880, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0410-2020
Recall number
D-0410-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
483,528 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17251 8/19 17269 9/19 17360 12/19 18012 1/20 18106 4/20 18275 11/20 18275 11/20

Distribution pattern

U.S.A. Nationwide

drug · product 58 of 134

CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #317912, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0411-2020
Recall number
D-0411-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
464,424 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

18229 9/21 18031 1/21 17131 5/20 17059 3/20 17008 1/20 19056 03/22

Distribution pattern

U.S.A. Nationwide

drug · product 59 of 134

CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Item#: 563431, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0412-2020
Recall number
D-0412-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
222,096 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

18043 2/20 18115 5/20 18300 12/20 18300 12/20 18116 5/20 18115 5/20 18044 2/20 18043 2/20

Distribution pattern

U.S.A. Nationwide

drug · product 60 of 134

CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0413-2020
Recall number
D-0413-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
24,024 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

QHE 08/19 QJD 10/19

Distribution pattern

U.S.A. Nationwide

drug · product 61 of 134

iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Sterile, Net Wt: 3.5 g (1.8 oz), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-190-50

D-0414-2020
Recall number
D-0414-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
6,877 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

SKG 11/21 12/28/2018 TAQ 01/22 04/23/2019

Distribution pattern

U.S.A. Nationwide

drug · product 62 of 134

Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC 59390-181-13

D-0415-2020
Recall number
D-0415-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
306,479 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17205 07/19 08/31/2017 17206 07/19 09/13/2017 17271 09/19 11/08/2017 18003 01/20 03/06/2018 18097 04/20 05/11/2018 18166 07/20 07/26/2018 18227 09/20 10/05/2018 18246 10/20 11/16/2018 18317 12/20 12/18/2018 19080 03/21 04/22/2019 19106 04/21

Distribution pattern

U.S.A. Nationwide

drug · product 63 of 134

ActivEyes Altachlore Sodium Chloride Hypertonicity Opthalmic Ointment, 5%, Manufactured by: Altaire Pharmaceuticals Inc. Aquebogue, NY 11931, NDC 59390-184-50

D-0416-2020
Recall number
D-0416-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
46345 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

SAP 1/20 3/16/2018 SFI 6/20 8/16/2018 SLA 12/20 1/4/2019 TBM 2/21

Distribution pattern

U.S.A. Nationwide

drug · product 64 of 134

ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., Aquebogue, NY 11931, NDC 59390-183-13

D-0417-2020
Recall number
D-0417-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
22494 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

18008 1/20 8/13/2018 19050 2/22 3/18/2019 19105 4/22

Distribution pattern

U.S.A. Nationwide

drug · product 65 of 134

ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50

D-0418-2020
Recall number
D-0418-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
161077 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

RJH 10/20 1/10/2018 RLL 12/20 8/22/2018 SGH 07/21 8/23/2018 SIF 09/21 10/16/2018 SKC 11/21 12/12/2018 TCG 03/22

Distribution pattern

U.S.A. Nationwide

drug · product 66 of 134

Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL, Altaire Pharmaceuticals, Inc Aquebogue, NY 11931 NDC 59390-217-02

D-0419-2020
Recall number
D-0419-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
3060 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

18164 7/20

Distribution pattern

U.S.A. Nationwide

drug · product 67 of 134

Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-217-10

D-0420-2020
Recall number
D-0420-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
636 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

18164 7/20

Distribution pattern

U.S.A. Nationwide

drug · product 68 of 134

Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 2.5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-02

D-0421-2020
Recall number
D-0421-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
390 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17247 8/19

Distribution pattern

U.S.A. Nationwide

drug · product 69 of 134

Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx only, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-205-05

D-0422-2020
Recall number
D-0422-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
532,961 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17099 4/20 6/1/2017 17254 8/20 9/14/2017 17255 8/20 9/15/2017 17361 12/20 12/26/2017 17362 12/20 4/4/2018 18088 4/21 4/30/2018 18089 4/21 5/1/2018 18138 6/21 6/25/2018 18146 6/21 6/29/2018 18156 6/21 8/6/2018 18212 8/21 10/2/2018 18276 11/21 12/26/2018 19082 3/22 5/1/2019 19098 4/22 5/21/2019 16282 10/19 11/11/2016 16283 10/19

Distribution pattern

U.S.A. Nationwide

drug · product 70 of 134

Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13

D-0423-2020
Recall number
D-0423-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
48,542 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17241 8/20 8/24/2017 17322 10/20 12/21/2017 18169 7/20 7/30/2018 19052 2/22

Distribution pattern

U.S.A. Nationwide

drug · product 71 of 134

Altaire Sterile Eye Wash, 30 mL (1 fl oz.), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-18

D-0424-2020
Recall number
D-0424-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
414,346 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17200 7/19 17322 10/20 18026 1/21 18100 4/21 18236 9/21 19052 2/22

Distribution pattern

U.S.A. Nationwide

drug · product 72 of 134

Altaire Sterile Eye Wash, 118 mL (4 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-35

D-0425-2020
Recall number
D-0425-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
809,600 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17087 3/20 17088 3/20 17109 4/20 17110 4/20 17306 10/20 17307 10/20 17318 10/20 17323 10/20 18014 1/21 18045 2/21 18059 3/21 18063 3/21 18117 5/21 18134 5/21 18228 9/21 18261 10/21 19119 4/22 16207 8/19 16233 8/19 16250 9/19 16268 10/19 16301 11/19

Distribution pattern

U.S.A. Nationwide

drug · product 73 of 134

Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-182-13

D-0426-2020
Recall number
D-0426-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
202266 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17112 4/20 17303 10/20 18032 2/21 18072 3/21 18193 8/20 18235 9/21 18285 11/21 19004 1/22 19102 4/22 16260 9/19

Distribution pattern

U.S.A. Nationwide

drug · product 74 of 134

iSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops Sterile, 0.33 FL OZ (10 mL), Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-208-10

D-0427-2020
Recall number
D-0427-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
137 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

19122 4/21

Distribution pattern

U.S.A. Nationwide

drug · product 75 of 134

iSolutions Nano Tears MO Clear Emollient Lubricant Drops Intensive Sterile, 10 mL, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390- 145-10

D-0428-2020
Recall number
D-0428-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
2,392 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

18052 2/20

Distribution pattern

U.S.A. Nationwide

drug · product 76 of 134

iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-144-10

D-0429-2020
Recall number
D-0429-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
13,407 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17367 12/19 18102 4/20 18174 7/20

Distribution pattern

U.S.A. Nationwide

drug · product 77 of 134

iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry Eye Therapy, 0.25 FL OZ (7.5 mL), Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-52

D-0430-2020
Recall number
D-0430-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
24 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

19123 4/21

Distribution pattern

U.S.A. Nationwide

drug · product 78 of 134

iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-147-56

D-0431-2020
Recall number
D-0431-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
48,973 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

RGK 7/19 SDA 4/20 SFH 6/20 TAN 1/21

Distribution pattern

U.S.A. Nationwide

drug · product 79 of 134

Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct., Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-56

D-0432-2020
Recall number
D-0432-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
13,375 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

RGI 7/19 SDB 4/20 TAA 1/21

Distribution pattern

U.S.A. Nationwide

drug · product 80 of 134

Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-49

D-0433-2020
Recall number
D-0433-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
1,666 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

18033 2/20

Distribution pattern

U.S.A. Nationwide

drug · product 81 of 134

iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replenishment Mild Sterile, 0.5 FL OZ (15 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-13

D-0434-2020
Recall number
D-0434-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
4409 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17366, Exp 12/19

Distribution pattern

U.S.A. Nationwide

drug · product 82 of 134

iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ (10 mL), Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-143-10

D-0435-2020
Recall number
D-0435-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
12,716 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17366 12/19 18103 /20 18173 7/20

Distribution pattern

U.S.A. Nationwide

drug · product 83 of 134

Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05

D-0436-2020
Recall number
D-0436-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
102,939 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17244 8/19 18057 3/20 518307 12/20

Distribution pattern

U.S.A. Nationwide

drug · product 84 of 134

ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-148-52

D-0437-2020
Recall number
D-0437-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
88 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

19015 1/21

Distribution pattern

U.S.A. Nationwide

drug · product 85 of 134

ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-146-52

D-0438-2020
Recall number
D-0438-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
47 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

18099 4/20

Distribution pattern

U.S.A. Nationwide

drug · product 86 of 134

ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931,NDC 59390-189-50

D-0439-2020
Recall number
D-0439-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
48 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

SFE 06/21

Distribution pattern

U.S.A. Nationwide

drug · product 87 of 134

OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05

D-0440-2020
Recall number
D-0440-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
81403 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17186 6/20 17345 11/20 19010 1/22 17041 2/2020 16217 8/19

Distribution pattern

U.S.A. Nationwide

drug · product 88 of 134

Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15

D-0441-2020
Recall number
D-0441-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
88,008 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17205 7/19 17206 7/19 18003 1/20 18097 4/20 18166 7/20 18292 11/20 19106 4/21

Distribution pattern

U.S.A. Nationwide

drug · product 89 of 134

OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO Box 429 Richmond, TX 77406-0429, NDC 54799-503-15

D-0442-2020
Recall number
D-0442-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
75996 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17303 10/20 18032 2/21 18235 9/21 18285 11/21 19021 1/22 16260 9/19

Distribution pattern

U.S.A. Nationwide

drug · product 90 of 134

OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492 Richmond TX 77406-0429 800-233-5469 Made in USA, Mfg. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-504-01

D-0443-2020
Recall number
D-0443-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
9518 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17217 7/19 11/10/2017 18256 10/20 17236 8/31/2019 17334 11 /30/2019 18015 1/31/2020

Distribution pattern

U.S.A. Nationwide

drug · product 91 of 134

OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05

D-0444-2020
Recall number
D-0444-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
103856 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17198, Exp 7/19; 17199, Exp 7/19; 17233, Exp 8/19; 17337, Exp 11/19; 17338, Exp 11/19; 18248, Exp 10/20

Distribution pattern

U.S.A. Nationwide

drug · product 92 of 134

OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-505-01

D-0445-2020
Recall number
D-0445-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
14091 cartons.

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17236 8/19 17334 11/19 18015 1/20

Distribution pattern

U.S.A. Nationwide

drug · product 93 of 134

OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA, NDC 54799-505-05

D-0446-2020
Recall number
D-0446-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
105609 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17232 8/19 17334 11/19 18249 10/20 19125 4/21

Distribution pattern

U.S.A. Nationwide

drug · product 94 of 134

OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-565-01

D-0447-2020
Recall number
D-0447-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
55,134 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

18026 1/21 18100 4/21 19052 2/22 19130 5/22

Distribution pattern

U.S.A. Nationwide

drug · product 95 of 134

OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59

D-0448-2020
Recall number
D-0448-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
296,314 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

16268 10/19 11/07/2016 16301 11/19 12/09/2016 17088 3/20 4/28/2017 17109 4/20 6/14/2017 17318 10/20 11/10/2017 17323 10/20 1/12/2018 18014 1/21 2/21/2018 18045 2/21 3/16/2018 18059 3/21 5/25/2018 18063 3/21 18117 5/21 18134 5/2

Distribution pattern

U.S.A. Nationwide

drug · product 96 of 134

OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21

D-0449-2020
Recall number
D-0449-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
427,280 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17255 8/20 17362 12/20 18089 4/21 18138 6/21 6/22/2018 18146 6/21 18210 8/21 18211 8/21 18272 11/21 18273 11/21 18276 11/21 16283 10/31/2019

Distribution pattern

U.S.A. Nationwide

drug · product 97 of 134

OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15

D-0450-2020
Recall number
D-0450-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
81217 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17209 7/21 18168 7/22 18217 8/22 18260 10/22 19094 4/23

Distribution pattern

U.S.A. Nationwide

drug · product 98 of 134

OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30

D-0451-2020
Recall number
D-0451-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
29326 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17208 7/21 17209 7/21 19001 1/23

Distribution pattern

U.S.A. Nationwide

drug · product 99 of 134

OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA

D-0452-2020
Recall number
D-0452-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
19632 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: SAP 1/20 SFI 6/20 TCI 3/21

Distribution pattern

U.S.A. Nationwide

drug · product 100 of 134

OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA

D-0453-2020
Recall number
D-0453-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
13626 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 18008 1/20 19105 4/22

Distribution pattern

U.S.A. Nationwide

drug · product 101 of 134

CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0454-2020
Recall number
D-0454-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
50,304 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 19087 03/21 18122 5/20 17289 9/19

Distribution pattern

U.S.A. Nationwide

drug · product 102 of 134

Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL, Sterile, Rx only, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-192-05

D-0455-2020
Recall number
D-0455-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
23974 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17041 2/20 17186 6/20 18068 3/21

Distribution pattern

U.S.A. Nationwide

drug · product 103 of 134

CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0456-2020
Recall number
D-0456-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17238 08/19 18094 4/20 19058 02/21

Distribution pattern

U.S.A. Nationwide

drug · product 104 of 134

Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA, Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04

D-0457-2020
Recall number
D-0457-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
90,072 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

16250 09/19 17088 03/20 17307 10/20 17323 10/20 18014 1/21 18228 9/21 18261 10/21 19119 4/22

Distribution pattern

U.S.A. Nationwide

drug · product 105 of 134

Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04

D-0458-2020
Recall number
D-0458-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
90072 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

18095 4/20

Distribution pattern

U.S.A. Nationwide

drug · product 106 of 134

Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By Grandall Distributing Co.Inc., Glendale, CA 91204-2707

D-0459-2020
Recall number
D-0459-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
73,548 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17131 5/20 18031 1/21 19065 3/22

Distribution pattern

U.S.A. Nationwide

drug · product 107 of 134

Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05

D-0461-2020
Recall number
D-0461-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
49527 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17225 07/19 17247 08/19 18038 02/20 18162 06/20 19014 01/21

Distribution pattern

U.S.A. Nationwide

drug · product 108 of 134

Natural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL, NDC 68770-143-15

D-0462-2020
Recall number
D-0462-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
81969 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17210 7/19 17378 12/19 18175 7/20

Distribution pattern

U.S.A. Nationwide

drug · product 109 of 134

Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15

D-0463-2020
Recall number
D-0463-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
41925 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17281 9/19 18120 5/20

Distribution pattern

U.S.A. Nationwide

drug · product 110 of 134

Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15

D-0464-2020
Recall number
D-0464-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
84216 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17375 12/19 17376 12/19 18190 7/20 18191 8/20

Distribution pattern

U.S.A. Nationwide

drug · product 111 of 134

Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops, 15 mL, NDC 68770-104-15

D-0465-2020
Recall number
D-0465-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
41906 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17374 12/19 18196 8/20

Distribution pattern

U.S.A. Nationwide

drug · product 112 of 134

Natural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL, 25 mL, NDC 68770-130-15

D-0466-2020
Recall number
D-0466-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
61830 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17282 9/19 18121 5/20

Distribution pattern

U.S.A. Nationwide

drug · product 113 of 134

Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15

D-0467-2020
Recall number
D-0467-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
20666 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17282 9/19 18121 5/20

Distribution pattern

U.S.A. Nationwide

drug · product 114 of 134

TRP/ TARGET up & up intensive relief lubricating eye drop, 10 mL

D-0468-2020
Recall number
D-0468-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17290 9/19 18052 2/20

Distribution pattern

U.S.A. Nationwide

drug · product 115 of 134

TRP Blur Relief, 15 mL, NDC 17312-002-11

D-0469-2020
Recall number
D-0469-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
24144 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

16256 09/19 17194 7/20

Distribution pattern

U.S.A. Nationwide

drug · product 116 of 134

TRP Stye Relief, 4 g, NDC 17312-014-13

D-0470-2020
Recall number
D-0470-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
318,412 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

RHP 8/19 RLD 12/19 SDE 4/20 SID 9/20

Distribution pattern

U.S.A. Nationwide

drug · product 117 of 134

TRP Pink Eye Relief, 10 mL, NDC 17312-013-15

D-0471-2020
Recall number
D-0471-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
1,381,638 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17185 6/20 17228 7/20 17349 11/20 18073 3/21 18218 8/21 18303 12/21

Distribution pattern

U.S.A. Nationwide

drug · product 118 of 134

Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, NDC 59390-144-51

D-0472-2020
Recall number
D-0472-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

17367 12/19 18174 7/20

Distribution pattern

U.S.A. Nationwide

drug · product 119 of 134

Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-35

D-0473-2020
Recall number
D-0473-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
273,100 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

RJH 10/19 SCC 3/21 SGA 7/21 SGH 7/21 SHH 8/21 SLL 12/21 TAC 1/22

Distribution pattern

U.S.A. Nationwide

drug · product 120 of 134

Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20

D-0474-2020
Recall number
D-0474-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
195,864 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

RKM 11/19 SGA 7/20 SIF 9/20 SKE 11/20

Distribution pattern

U.S.A. Nationwide

drug · product 121 of 134

Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52

D-0475-2020
Recall number
D-0475-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

19015 01/21 19117 04/21 18080 07/20 18111 05/20

Distribution pattern

U.S.A. Nationwide

drug · product 122 of 134

CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 634634, Product Size: 0.6 mL x 30, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0476-2020
Recall number
D-0476-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
114504 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

SEI 5/20 TAK 01/21

Distribution pattern

U.S.A. Nationwide

drug · product 123 of 134

CVS Health Multi-Action Relief Drops, Item#: 694954, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0477-2020
Recall number
D-0477-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 16267, Exp 10/19; 18096, Exp 04/21; 18301, Exp 12/21; 18096, Exp 4/21; 18301, Exp 12/21; 17371, Exp 12/20; 17158, Exp 6/20; 17025, Exp 1/20; 17015, Exp 1/20; 19103, Exp 04/22

Distribution pattern

U.S.A. Nationwide

drug · product 124 of 134

Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05

D-0478-2020
Recall number
D-0478-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
6024 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 18164, Exp 7/20

Distribution pattern

U.S.A. Nationwide

drug · product 125 of 134

Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-144-51

D-0479-2020
Recall number
D-0479-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
2870 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17367, Exp 12/19; 18174, Exp 7/20

Distribution pattern

U.S.A. Nationwide

drug · product 126 of 134

Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-143-51

D-0480-2020
Recall number
D-0480-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17366, Exp 12/19

Distribution pattern

U.S.A. Nationwide

drug · product 127 of 134

OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-76

D-0481-2020
Recall number
D-0481-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
19632 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: SAP 1/20 3/16/2018 SFI 6/20 10/29/2018 TCI 3/21

Distribution pattern

U.S.A. Nationwide

drug · product 128 of 134

OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77

D-0482-2020
Recall number
D-0482-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 18008 1/20 19105 4/22

Distribution pattern

U.S.A. Nationwide

drug · product 129 of 134

FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15

D-0483-2020
Recall number
D-0483-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
31070 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 18095, Exp 4/20

Distribution pattern

U.S.A. Nationwide

drug · product 130 of 134

Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL

D-0485-2020
Recall number
D-0485-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
73548 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 17008, Exp 01/20

Distribution pattern

U.S.A. Nationwide

drug · product 131 of 134

Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g

D-0486-2020
Recall number
D-0486-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: QJD, Exp 10/19; RFK, Exp 6/20; SCB, Exp 3/21; TBI, Exp 2/22

Distribution pattern

U.S.A. Nationwide

drug · product 132 of 134

Clear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6

D-0487-2020
Recall number
D-0487-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 16195, Exp 7/19; 16211, Exp 8/19; 16216, Exp 8/19

Distribution pattern

U.S.A. Nationwide

drug · product 133 of 134

Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7

D-0489-2020
Recall number
D-0489-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 16192, Exp 7/19; 16203, Exp 7/19; 16242, Exp 9/19; 16280, Exp 10/19; 16285, Exp 10/19; 16300, Exp 11/19; 16336, Exp 12/19; 17002, Exp 1/20; 17012, Exp 1/20; 17051, Exp 2/20; 17130, Exp 04/20; 17147, Exp 05/20

Distribution pattern

U.S.A. Nationwide

drug · product 134 of 134

Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7

D-0490-2020
Recall number
D-0490-2020
Initiated
July 02, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 16321, Exp 11/19; 16336, Exp 12/19; 17012, Exp 1/20; 17034, Exp 2/20; 17051, Exp 2/20; 17147, Exp 5/20

Distribution pattern

U.S.A. Nationwide

Field note

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