🍔 Food 💊 Drugs 🏥 Medical Devices
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07. Class III

Reason: Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).

QuVa Pharma, Inc. 20220920 Terminated
Distributed: Nationwide in the USA
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Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15. Class II

Reason: CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.

Novartis Pharmaceuticals Corporation 20220916 Terminated
Distributed: Nationwide and Puerto Rico
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Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A Class II

Reason: Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.

Viatris Inc 20220921 Terminated
Distributed: Nationwide in the USA
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Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90. Class III

Reason: Superpotent Drug: Out of specification for assay at the 12-month timepoint.

SUN PHARMACEUTICAL INDUSTRIES INC 20220621 Terminated
Distributed: Nationwide in the USA
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Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90. Class III

Reason: Superpotent Drug: Out of specification for assay at the 12-month timepoint.

SUN PHARMACEUTICAL INDUSTRIES INC 20220621 Terminated
Distributed: Nationwide in the USA
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Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01 Class III

Reason: Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

UNICHEM PHARMACEUTICALS USA INC 20220919 Terminated
Distributed: Distributed Nationwide in the USA
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PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Class I

Reason: Presence of particulate matter

Pfizer Inc. 20220822 Terminated
Distributed: USA Nationwide
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Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02. Class II

Reason: Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.

Teva Pharmaceuticals USA Inc 20220829 Terminated
Distributed: Nationwide in the US.
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Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00 Class II

Reason: Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.

RemedyRepack Inc. 20220915 Terminated
Distributed: Distributed to two direct accounts in PA and AK.
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Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are not available, Alcohol 80% Topical Solution, Antiseptic, 8.5 oz./ 250 mL bottles, Made and Distributed by: Superior Glove Works Ltd., 36 Vimy Street, Acton, Ontario, L7J 1S1, Canada, Made in Canada, UPC: 779406201594. Class II

Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.

SUPERIOR GLOVE WORKS, LTD. 20220901 Terminated
Distributed: Nationwide in the US.
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