FDA Drug Recalls

NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.

Pharmedium Services, LLC

Subpotent Drug

NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.

Pharmedium Services, LLC

Subpotent Drug

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.

Akorn Inc

Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.

NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.

Pharmedium Services, LLC

Subpotent Drug

December 13, 2019 · DrugView details →

Class IIOngoing

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

Granules India Limited

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

December 13, 2019 · DrugView details →

Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.

December 13, 2019 · DrugView details →

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61

The Harvard Drug Group

Failed Dissolution Specifications: High out of specification result observed at stability studies.

December 11, 2019 · DrugView details →

Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00

RemedyRepack Inc.

CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

December 11, 2019 · DrugView details →

Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.

Spectrum Laboratory Products

Subpotent Drug: Supplier indicated assay results did not meet specifications.

December 10, 2019 · DrugView details →

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA

Lupin Pharmaceuticals Inc.

Failed Dissolution Specifications: High out of specification result observed at stability studies.

December 9, 2019 · DrugView details →

Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36

Asclemed USA Inc. dba Enovachem Pharmaceuticals

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

December 9, 2019 · DrugView details →

Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37

Asclemed USA Inc. dba Enovachem Pharmaceuticals

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

December 9, 2019 · DrugView details →

Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38

Asclemed USA Inc. dba Enovachem Pharmaceuticals

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Class ITerminated

Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80

Lannett Company, Inc.

Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.

December 6, 2019 · DrugView details →

December 4, 2019 · DrugView details →

Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11

American Health Packaging

Failed Dissolution Specifications: Low out of specification results obtained during stability testing.

December 2, 2019 · DrugView details →

Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals

Preferred Pharmaceuticals, Inc

CGMP Deviations: Presence of NDMA impurity detected in product.

December 2, 2019 · DrugView details →

Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.

AuroMedics Pharma LLC

Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.