Drug Recall
Ongoing
Historical recordClass II
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
by Granules India Limited
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Recall initiated
- December 13, 2019
- Reported by FDA
- January 8, 2020
- Distribution
- OR, NY, NJ
View recall →
Drug Recall
Terminated
Historical recordClass II
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
by American Health Packaging
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- November 1, 2019
- Reported by FDA
- January 8, 2020
- Distribution
- Nationwide USA
View recall →
Drug Recall
Terminated
Historical recordClass II
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.
by Spectrum Laboratory Products
- Reason
- Subpotent Drug: Supplier indicated assay results did not meet specifications.
- Recall initiated
- December 11, 2019
- Reported by FDA
- January 1, 2020
- Distribution
- Nationwide in the USA and Canada
View recall →
Drug Recall
Terminated
Historical recordClass III
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.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Recall initiated
- December 16, 2019
- Reported by FDA
- January 1, 2020
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass III
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.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Recall initiated
- December 16, 2019
- Reported by FDA
- January 1, 2020
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass III
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.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Recall initiated
- December 16, 2019
- Reported by FDA
- January 1, 2020
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass II
Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
by AuroMedics Pharma LLC
- Reason
- Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
- Recall initiated
- November 19, 2019
- Reported by FDA
- December 25, 2019
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass I
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
by Lannett Company, Inc.
- Reason
- Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
- Recall initiated
- December 6, 2019
- Reported by FDA
- December 25, 2019
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass III
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
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Dissolution Specifications: High out of specification result observed at stability studies.
- Recall initiated
- December 10, 2019
- Reported by FDA
- December 25, 2019
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass III
VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771.
by Apothecus Pharmaceutical Corp.
- Reason
- Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
- Recall initiated
- November 25, 2019
- Reported by FDA
- December 25, 2019
- Distribution
- Nationwide in the US and Canada
View recall →
Drug Recall
Terminated
Historical recordClass II
Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA
by Medisca, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Recall initiated
- November 25, 2019
- Reported by FDA
- December 25, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass I
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
by AuroMedics Pharma LLC
- Reason
- Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
- Recall initiated
- November 20, 2019
- Reported by FDA
- December 18, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass I
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
by AuroMedics Pharma LLC
- Reason
- Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
- Recall initiated
- November 20, 2019
- Reported by FDA
- December 18, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541), Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011
by OraLabs, Incorporated
- Reason
- Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
- Recall initiated
- November 25, 2019
- Reported by FDA
- December 18, 2019
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass II
Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
by SCA Pharmaceuticals, LLC
- Reason
- Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
- Recall initiated
- November 26, 2019
- Reported by FDA
- December 18, 2019
- Distribution
- nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Defective delivery system; product is not foaming or is coming out as liquid.
- Recall initiated
- November 15, 2019
- Reported by FDA
- December 18, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas Inc. USA Mahwah, NJ 07430
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Defective delivery system; product is not foaming or is coming out as liquid.
- Recall initiated
- November 15, 2019
- Reported by FDA
- December 18, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
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
by Preferred Pharmaceuticals, Inc
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Recall initiated
- December 2, 2019
- Reported by FDA
- December 18, 2019
- Distribution
- CA, FL
View recall →
Drug Recall
Ongoing
Historical recordClass II
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
by Amneal Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Recall initiated
- November 22, 2019
- Reported by FDA
- December 18, 2019
- Distribution
- Product was distributed throughout the United States.
View recall →
Drug Recall
Ongoing
Historical recordClass II
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
by Amneal Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Recall initiated
- November 22, 2019
- Reported by FDA
- December 18, 2019
- Distribution
- Product was distributed throughout the United States.
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
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