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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90948

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

Open FDA event record

Event summary

Timeline bucket
October 13, 2022
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Akorn, 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

27 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 27

AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35

D-0132-2023
Recall number
D-0132-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
36,025 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot # 0G87A, EXP 06/30/2023

Distribution pattern

Nationwide in the USA

drug · product 2 of 27

Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35

D-0133-2023
Recall number
D-0133-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
1,164,171 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot # 0A08B, EXP 12/31/2022; 0B63A, EXP 1/31/2023; 0C72A, EXP 2/28/2023; 0D14A, 0D19A, EXP 3/31/2023; 0F54A, EXP 5/31/2023; 0G80B, 0G09B, 0G97A, EXP 6/30/2023; 0J78A, EXP 8/31/2023; 0K23A, EXP 9/30/2023; 0L64A, EXP 10/31/2023;1B29A, EXP 1/31/2024; 1C59A, 1C53A, 1C72A,1C78A, EXP 2/29/2024; 1D87A, 1D89A, EXP 3/31/2024; 1G59A, 1G59B, EXP 6/30/2024; 1K60A, EXP 9/30/2024; 1J57A, EXP 8/31/2024; 1H86A, EXP 7/31/2024; 1K75A, EXP 9/30/2024; 1L12A, EXP 10/31/2024; 1M22A, EXP 11/30/2024

Distribution pattern

Nationwide in the USA

drug · product 3 of 27

Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12

D-0134-2023
Recall number
D-0134-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
967,075 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 0L44A, 0L52A, 0L51A, 0L77A, 0L75A, EXP 10/31/2022; 0M02A, 0M01A, EXP 11/30/2022; 1C81A, EXP 2/28/2023; 1D02A, 1D03A, EXP 3/31/2023; 1E10A, 1E08A, 1E23A, 1E26A, 1E25A, 1E27A, 1E33A, EXP 4/30/2023; 1F46A, EXP 5/31/2023; 1G49A, 1G50A, 1G67A, EXP 6/30/2023; 1H04A, 1H74A,1H76A, 1H05A, 1H07A, 1H15A, 1H13A, 1H95A, EXP 7/31/2023; 1J44A, 1J20A, EXP 8/31/2023;

Distribution pattern

Nationwide in the USA

drug · product 4 of 27

Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10

D-0135-2023
Recall number
D-0135-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
6,273 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 1A08A, EXP 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 5 of 27

Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25

D-0136-2023
Recall number
D-0136-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
1,584 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: Lot 1E22A, EXP 10/31/2022

Distribution pattern

Nationwide in the USA

drug · product 6 of 27

Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11

D-0137-2023
Recall number
D-0137-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
188,550 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 0G75A, 0G12A, EXP 6/30/2023; 0H50A, EXP 7/31/2023; 0J88A, EXP 8/31/2023; 1D98A, EXP 3/31/2024; 1E31A, EXP 4/30/2024; 1D97A, EXP 3/31/2024; 1H14A, EXP 7/31/2024;

Distribution pattern

Nationwide in the USA

drug · product 7 of 27

ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35

D-0138-2023
Recall number
D-0138-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
1,109,600 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 0L58A, EXP 10/31/2022; 1B21A, 1B31A, EXP 1/31/2023; 1C44A, 1C58A, 1C58B, EXP 2/28/2023; 1E13A, 1E24A, EXP 4/30/2023; 1C57A, EXP 2/28/2023; 1G60A, 1G62A, 1G63A, EXP 6/30/2023; 1J34B, 1J40A, 1J21A, EXP 8/31/2023; 1K74A, EXP 9/30/2023; 1L93A, 1L96B, 1L96A, EXP 10/31/2023; 1M25A, 1M24A, 1M31A, EXP 11/30/2023; 2A02A, 2A10A, EXP 12/31/2023; 2C07A, EXP 2/29/2024; 2D47A, EXP 3/31/2024; 2E50A, 2E51A, EXP 4/30/2024;

Distribution pattern

Nationwide in the USA

drug · product 8 of 27

Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31

D-0139-2023
Recall number
D-0139-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
36,455 cartons

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 1B14B, EXP 1/31/2023; 1C49A, 1C49B, 1C70A, EXP 2/28/2023; 1E09A, 1E34A, 1E34B, 1E09B, EXP 4/30/2023; 1F37C, 1F37A, 1F37B, EXP 5/31/2023; 1G58A, 1G57B, 1G58B, 1G66B, 1G66A, 1G57A, EXP 6/30/2023; 1H77B, 1H80A, 1H80B, 1H77A, EXP 7/31/2023; 1J24A, EXP 8/31/2023; 1K67B, 1K67A, 1K76A, 1K87B, 1K77A, 1K76B, 1K87A, 1K77B, EXP 9/30/2023; 1L90B, 1L90A, 1L92B, 1L92A, EXP 10/31/2023; 1M28A, 1M35A, 1M28B, EXP 11/30/2023; 2D20B, EXP 3/31/2024.

Distribution pattern

Nationwide in the USA

drug · product 9 of 27

GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12

D-0140-2023
Recall number
D-0140-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
196,254 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 0C80A, EXP 2/28/2023; 0B71A, 1B32A, EXP 1/31/2023; 0C80B, EXP 2/28/2023; 0F68A, EXP 5/31/2023; 0G85A, 0G01A, 1G54A, 1G71A, EXP 6/30/2023; 0H32A, 0H47A, 1H75A, EXP 7/31/2023; 0K22A, EXP 9/30/2023; 0M90A, EXP 11/30/2023;

Distribution pattern

Nationwide in the USA

drug · product 10 of 27

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.

D-0141-2023
Recall number
D-0141-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
314,543 10ml,3ml, 5ml bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: (a) 1A09A, EXP 12/31/2022; 1H01A, EXP 7/31/2023 ; (b) 1E32A, EXP 4/30/2023; 1F45A, EXP 5/31/2023; 1H99A, EXP 7/31/2023; 1K84A, EXP 9/30/2023; (c) 0L40A, EXP 10/31/2022; 1B38A, EXP 1/31/2023; 1E12A, EXP 4/30/2023; 1F41A, EXP 5/31/2023; 1G73A, 1G68A, EXP 6/30/2023; 1H08A, 1H12A, EXP 7/31/2023

Distribution pattern

Nationwide in the USA

drug · product 11 of 27

Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10

D-0142-2023
Recall number
D-0142-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
3108 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot # 1F43A, EXP 5/31/2/023

Distribution pattern

Nationwide in the USA

drug · product 12 of 27

Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.

D-0143-2023
Recall number
D-0143-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
2,369,258 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: (a) 0A02B, 0A02D, 0A02C, 0A02A, 0A02E, EXP 12/31/2022; 0B60C, 0B46B, 0B60D EXP 1/31/2023; 0B67B, 0B67D, 0B60B, 0B60A, 0B67A, 0B46D, 0B67C, 0B46A, EXP 1/31/2023; 0C78B, 0C78D, 0C78C, EXP 2/28/2023; 0D11A, 0D11C, 0D11B, 0D11D, EXP 3/31/2023 0E35C, 0E35B, 0E35A, EXP 4/30/2023; 0J63B, 0J63C, EXP 8/31/2023; 0K02A, 0K02C, 0K02D, 0K02B, EXP 9/30/2023; 0L47B, 0L47C, 0L47A, EXP 10/31/2023; 1B12B, 1B12A, 1B23A, 1B23F, 1B12C, 1B23B, 1B23D, 1B23E, 1B12D, EXP 1/31/2024; 1C66C, 1C66A, EXP 2/29/2024; 1D93B, 1D93D, 1D93C, 1D99B, 1D99C, 1D99A, 1D93A, 1D99D, EXP 3/31/2024 1H96C, 1H96D, 1H96E, EXP 7/31/2024; 1J37B, 1J47B, 1J47D, 1J37C, 1J37A, 1J47C, EXP 8/31/2024; 1L18D, 1L98C, 1L18C, 1L18A, 1L98B, 1L98D, 1L18B, 1L98E, EXP 10/31/2024; 2D21B, EXP 3/31/2025 (b) 0A06A, 0A37A , EXP 12/31/2022; 0B44A, EXP 1/31/2023; 0C88A, 0C84A, EXP 2/28/2023; 0D21A, 0D08A, EXP 3/31/2023; 0E46A, 0E46B, 0E31A, 0E48A, EXP 4/30/2023; 0F72A, 0F58A, EXP 5/31/2023; 0G05A, EXP 6/30/2023; 0H41A, EXP 7/31/2023; 0J67A, 0J67B, EXP 8/31/2023; 0K15B, 0K15A, EXP 9/30/2023; 0L56B, EXP 10/31/2023; 1B20A, EXP 1/31/2024; 1C47A, 1C52A, EXP 2/29/2024; 1D84B,1D84A, EXP 3/31/2024; 1G61A, 1G64A, 1G72A, EXP 6/30/2024; 1J51A, 1J28A, EXP 8/31/2024; 1K63A, 1K69A, 1K73A, 1K69B, 1K69C, EXP 9/30/2024; 1L15B, EXP 10/31/2024; 2C08A,EXP 2/28/2025;

Distribution pattern

Nationwide in the USA

drug · product 13 of 27

Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19

D-0144-2023
Recall number
D-0144-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
2,563 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot, Expiry: Lots 1E28A, exp 4/30/2023

Distribution pattern

Nationwide in the USA

drug · product 14 of 27

Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35

D-0145-2023
Recall number
D-0145-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
2,082 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: Lot 1K64A, EXP 9/30/2023

Distribution pattern

Nationwide in the USA

drug · product 15 of 27

Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05

D-0146-2023
Recall number
D-0146-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
65,006 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 11B26A, EXP 1/31/2023; 1H02A, EXP 7/31/2023;

Distribution pattern

Nationwide in the USA

drug · product 16 of 27

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05

D-0147-2023
Recall number
D-0147-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
31,073 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: Lot 1B41A, EXP 1/31/2023

Distribution pattern

Nationwide in the USA

drug · product 17 of 27

Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05

D-0148-2023
Recall number
D-0148-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
1,752 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 1L03A, EXP 10/31/2023

Distribution pattern

Nationwide in the USA

drug · product 18 of 27

Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12

D-0149-2023
Recall number
D-0149-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
173,928 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 0L48A, EXP 10/31/2022; 0L55A, EXP 10/31/2022; 1C75A, EXP 2/28/2023; 1E18A, 1E20A , EXP 4/30/2023;

Distribution pattern

Nationwide in the USA

drug · product 19 of 27

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05

D-0150-2023
Recall number
D-0150-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
163,996 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 1L16A, 1L17A, EXP 10/31/2023; 1M29A, EXP 11/30/2023; 2A05A, EXP 12/31/2023;

Distribution pattern

Nationwide in the USA

drug · product 20 of 27

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05

D-0151-2023
Recall number
D-0151-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
121,176 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 1C61A, EXP 2/28/2023; 1D86A, 1D07A, EXP 3/31/2023;

Distribution pattern

Nationwide in the USA

drug · product 21 of 27

PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12

D-0152-2023
Recall number
D-0152-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
51,601 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 0B55A, EXP 1/31/2023; 0D16A, 0D23A, EXP 3/31/2023; 0E51A, EXP 4/30/2023; 1C46A, EXP 2/29/2024;

Distribution pattern

Nationwide in the USA

drug · product 22 of 27

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12

D-0153-2023
Recall number
D-0153-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
267,678 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 0L42A, 0L50A, EXP 10/31/2022; 1C64A, 1C76A, EXP 2/28/2023; 1G53A, EXP 6/30/2023; 1J26A, 1J25A, 1J48A, 1J54A, EXP 8/31/2023

Distribution pattern

Nationwide in the USA

drug · product 23 of 27

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15

D-0154-2023
Recall number
D-0154-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
23,026 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 0L53A, EXP 10/31/2022; 1J49A, EXP 8/31/2023;

Distribution pattern

Nationwide in the USA

drug · product 24 of 27

Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35

D-0155-2023
Recall number
D-0155-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
524,506 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 0F69A, EXP 5/31/2023; 0G92B, 0G92A, EXP 6/30/2023; 0J69A, EXP 8/31/2023; 0K29A, 0K24A, EXP 9/30/2023; 0M93A, 0M92A, 0M92B, EXP 11/30/2023; 1B25A, EXP 1/31/2024; 1C74A, EXP 2/29/2024; 1E19A, EXP 4/30/2024; 1C77A, EXP 2/29/2024;

Distribution pattern

Nationwide in the USA

drug · product 25 of 27

Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.

D-0156-2023
Recall number
D-0156-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
1,310,324 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: (a) 0B50A, 0B69A, EXP 1/31/2023; 0C74A, EXP 2/28/2023; 0D04A, EXP 3/31/2023; 0E37A, EXP 4/30/2023; 0G07A, 0G82A, EXP 6/30/2023; 0H26A, 0H28A, 0H53A, 0H36A, EXP 7/31/2023; 0J64A, 0J58A, 0J66A, EXP 8/31/2023; 0K96A, 0K06A, 0K98A, 0K04A, 0K03A, 0K99A, EXP 9/30/2023; 0L72A, EXP 10/31/2023; 0M81A, 0M85A, 0M80A, 0M84A, 0M82A, 0M83A, EXP 11/30/2023; 1A01A, 1A02A, EXP 12/31/2023; 1B16A, 1B13A, 1B17A, EXP 1/31/2024; 1C51A, EXP 2/29/2024; (b) 0B59A , EXP 1/31/2023;0E49A, EXP 4/30/2023; 0G14A, EXP 6/30/2023; 0H38A, EXP 7/31/2023; 0J84A, EXP 8/31/2023; 0K05A, EXP 9/30/2023; 0L59A, EXP 10/31/2023; 0M86A, 0M87A, EXP 11/30/2023; 1A03A, EXP 12/31/2023; 1B37A, EXP 1/31/2024; 1C63A, EXP 2/29/2024; 1C54A, EXP 2/29/2024; 1D83A, EXP 3/31/2024; (c) 0C82A, EXP 2/28/2023; 0G84A, EXP 6/30/2023; 0H49A, EXP 7/31/2023; 0J77A, EXP 8/31/2023; 0J75A, EXP 8/31/2023; 0L57A, EXP 10/31/2023; 0L74A, EXP 10/31/2023; 0L46A, EXP 10/31/2023; 1G52A, EXP 6/30/2024; 1J52A, EXP 8/31/2024;

Distribution pattern

Nationwide in the USA

drug · product 26 of 27

Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10

D-0157-2023
Recall number
D-0157-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
2,095,068 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 1C56A, EXP 2/28/2023; 1J50A, EXP 8/31/2023; 1K61A, EXP 9/30/2023 ; 1M27A, EXP 11/30/2023;

Distribution pattern

Nationwide in the USA

drug · product 27 of 27

Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05

D-0158-2023
Recall number
D-0158-2023
Initiated
October 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Akorn, Inc.
Quantity
91,692 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations:

Code information

Lot: 1D94A, EXP 3/31/2023; 1E35A, EXP 4/30/2023; 2A06A, EXP 12/31/2023

Distribution pattern

Nationwide in the USA

Field note

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