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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66566

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

Open FDA event record

Event summary

Timeline bucket
October 19, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Specialty Medicine Compounding Pharmacy

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

51 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 51

Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-410-2014
Recall number
D-410-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
20 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t10152013@22

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 2 of 51

Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-411-2014
Recall number
D-411-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
160 grams

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08132013@1, 08162013@5

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 3 of 51

Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-412-2014
Recall number
D-412-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
2801 doses

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: for both sizes: 08072013@26, 08282013@52, 09112013@31, 09162013@33, 10072013@33, 07242013@47, 08082013@42, 09172013@52, 10162013@35, 07242013@55, 07242013@56, 09122013@36, 09122013@35, 10042013@8, 10042013@9, 07262013@12, 07262013@13, 07262013@14, 07262013@16, 08082013@35, 08082013@41, 08152013@44, 08162013@21, 08292013@53, 08302013@24, 08302013@25, 08302013@35, 09062013@20, 09132013@26, 09132013@12, 09132013@13, 09202013@34, 09202013@35, 09202013@36, 09262013@24, 10092013@36, 10092013@39, 10102013@37, 10112013@34, 10162013@44, 10172013@26, 10172013@27

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 4 of 51

Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-413-2014
Recall number
D-413-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
44.44 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08222013@3

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 5 of 51

Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-414-2014
Recall number
D-414-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
38 doses

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10092013@4, 10162013@1

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 6 of 51

Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-415-2014
Recall number
D-415-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
180 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t08162013@15

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 7 of 51

CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-416-2014
Recall number
D-416-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
5 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09262013@1

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 8 of 51

DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-417-2014
Recall number
D-417-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
70 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09112013@1, 09232013@40, t09252013@26

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 9 of 51

EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-418-2014
Recall number
D-418-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
30 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t07312013@36, t09182013@5

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 10 of 51

EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-419-2014
Recall number
D-419-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
157.08 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10082013@7, 10152013@2, t10102013@1, t10092013@7, t10092013@6, t10142013@60, t10142013@61

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 11 of 51

FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-420-2014
Recall number
D-420-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
700 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10042013@7

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 12 of 51

FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-421-2014
Recall number
D-421-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
4.4 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09242013@1

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 13 of 51

Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-422-2014
Recall number
D-422-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
38 doses

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10092013@5, 10162013@2

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 14 of 51

Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-423-2014
Recall number
D-423-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
126 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10112013@1

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 15 of 51

GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-424-2014
Recall number
D-424-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
210 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07082013@7, t07112013@1, 08022013@9, t08142013@35, t08222013@15, t10042013@2

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 16 of 51

Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-425-2014
Recall number
D-425-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
148.075 ml

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s:09232013@3, 09102013@5, t09172013@20, 09252013@4, 09252013@7, 10022013@12, 10082013@6, 10142013@58, 10152013@1

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 17 of 51

HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-426-2014
Recall number
D-426-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
70 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t08122013@18, t09232013@8

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 18 of 51

HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-427-2014
Recall number
D-427-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
53 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09192013@10, 10152013@19

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 19 of 51

LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-428-2014
Recall number
D-428-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
65 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t08142013@39, t09052013@40, t09122013@3, t09122013@25

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 20 of 51

Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-429-2014
Recall number
D-429-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
19200 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07312013@41, 07312013@42, 07312013@43, 07312013@44, 07312013@45, 08012013@1, 08012013@2, 08012013@4, 08012013@6, 08012013@11, 08012013@3, 08012013@5, 08012013@7, 08012013@8, 08012013@9, 08012013@10

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 21 of 51

METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-430-2014
Recall number
D-430-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
20 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10042013@1

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 22 of 51

METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTABLE, METHYLCOBALAMIN* PF 1000 mcg/mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-431-2014
Recall number
D-431-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
726.45 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t10072013@4, 10192013@1, 07112013@3, 09052013@6, 09262013@2, 09272013@35, 10012013@26, 08282013@35, t08282013@17, t10092013@30, t10102013@18, t08222013@11, t08292013@21, t08302013@5, t09162013@30, 09162013@46, 09172013@23, t09242013@33, t09302013@25, t10022013@15, t10112013@21, t10162013@4, t08222013@21, t10092013@29

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 23 of 51

Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-432-2014
Recall number
D-432-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
186 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@10, 07012013@12, 07092013@14, 08132013@22, 08282013@1

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 24 of 51

NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-433-2014
Recall number
D-433-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
120 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08292013@10

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 25 of 51

NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-434-2014
Recall number
D-434-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
100 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09262013@3

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 26 of 51

Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-435-2014
Recall number
D-435-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
5582.6 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@8, 09242013@3, 09242013@4, 09242013@6, 09242013@7, 09242013@9, 10012013@1, 10012013@2, 10012013@3, 10012013@4, 10012013@5, 10012013@6, 10032013@6, 10142013@1

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 27 of 51

Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-436-2014
Recall number
D-436-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
35.5 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t07312013@20, t09162013@43, t08282013@18, t08292013@11

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 28 of 51

Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-437-2014
Recall number
D-437-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
1351 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08212013@13, 09112013@2, 09172013@17, 09232013@1, 09242013@13, 10022013@7, 09242013@14, 10022013@9, 10032013@5, 10072013@2

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 29 of 51

Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-438-2014
Recall number
D-438-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
11 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 07232013@41

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 30 of 51

Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-439-2014
Recall number
D-439-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
6 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09302013@6

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 31 of 51

Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-440-2014
Recall number
D-440-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
10 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t07312013@28

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 32 of 51

POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-441-2014
Recall number
D-441-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
600 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10032013@2, 10032013@1

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 33 of 51

Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-442-2014
Recall number
D-442-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
6 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09302013@8

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 34 of 51

QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, prostaglandin, atropine sulfate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-443-2014
Recall number
D-443-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
86 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s:t09192013@20, t07312013@12, t07312013@13, t09172013@30, t08142013@10, t08272013@28, t09052013@32, 09162013@40, t09252013@12

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 35 of 51

SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-444-2014
Recall number
D-444-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
9200 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@11, 09242013@12, 10022013@1, 10022013@2, 10082013@1, 10082013@2, 10082013@3, 10092013@1, 10092013@2, 10092013@3, 10152013@15, 09192013@1, 09192013@2, 09192013@3, 09192013@4, 09192013@6, 09192013@7, 09192013@8, 09202013@28, 09202013@29, 10032013@3, 10032013@4, 10152013@3, 10152013@4

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 36 of 51

Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-445-2014
Recall number
D-445-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
100 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t08302013@12

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 37 of 51

Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-446-2014
Recall number
D-446-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
180 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t10022013@6, 10162013@3, t10172013@10

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 38 of 51

HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-447-2014
Recall number
D-447-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
420 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07122013@1, 09162013@6

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 39 of 51

QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-448-2014
Recall number
D-448-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
15 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08262013@5

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 40 of 51

TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-449-2014
Recall number
D-449-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
33 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09182013@42, t09172013@31, t09182013@4

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 41 of 51

TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-450-2014
Recall number
D-450-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
17.5 ml

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08192013@34, t08272013@34, t10012013@28

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 42 of 51

TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-451-2014
Recall number
D-451-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
3000 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08282013@8, 09192013@9, 10142013@2

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 43 of 51

TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-452-2014
Recall number
D-452-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
5.5 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t10142013@30

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 44 of 51

TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-453-2014
Recall number
D-453-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
44 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t09032013@48, t09252013@37, 09162013@38

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 45 of 51

VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-454-2014
Recall number
D-454-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
50 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08222013@2

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 46 of 51

VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-455-2014
Recall number
D-455-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
204 doses

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10012013@23, 10012013@24, 10012013@25, 10012013@9, 10012013@12, 10012013@13, 10012013@15, 10012013@16, 10012013@17, 10012013@19, 10012013@20, 10012013@22

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 47 of 51

WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-456-2014
Recall number
D-456-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
a) 1900 injectable; b) 1900 mL topical

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable lots: 09272013@14, 09272013@4, 09272013@8, 09272013@18, 10142013@3, 10142013@9, 10142013@13, 10142013@15, 10142013@19, 09272013@3, 09272013@7, 09272013@11, 09272013@13, 09272013@17, 10142013@6, 10142013@8, 10142013@12, 10142013@18, 10142013@22; b) Topical lots: 09272013@2, 09272013@6, 09272013@10, 09272013@12, 09272013@16, 10142013@5, 10142013@7, 10142013@11, 10142013@17, 10142013@21, 09272013@5, 09272013@9, 09272013@15, 09272013@19, 10142013@4, 10142013@10, 10142013@14, 10142013@16, 10142013@20

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 48 of 51

Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-457-2014
Recall number
D-457-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
8090.8 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09202013@1, 09202013@2, 09202013@3, 09202013@4, 09202013@5, 09202013@6, 09202013@7, 09202013@8, 10102013@7, 10102013@3, 10102013@8

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 49 of 51

0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-458-2014
Recall number
D-458-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
a) Injectable 800 mL; b) Topical 600 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable 09252013@8, 09302013@2, 10152013@6; b) Topical 09252013@9, 09302013@5, 10152013@8

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 50 of 51

DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-459-2014
Recall number
D-459-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
a) Injectable 600 mL; b) Topical 800 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable 09252013@10, 09302013@1, 10152013@5, ; b) Topical 09252013@11, 09302013@3, 10152013@7

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

drug · product 51 of 51

SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-460-2014
Recall number
D-460-2014
Initiated
October 19, 2013
Classification
Class II
Status
Terminated
Quantity
10 mL

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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Code information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10152013@20

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

Field note

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