FDA Recall D-1345-2020

Amneal Pharmaceuticals of New York, LLC · Brookhaven, NY

Class II Ongoing 2176 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-50

Lot / code: AM180641A 6/30/2020 AM180642A 6/30/2020 AM180643A 6/30/2020 AM180644A 6/30/2020 AM180645A 6/30/2020 AM180646A 6/30/2020 AM180647A 6/30/2020 AM180880A 7/31/2020 AM180881A 7/31/2020 AM180882A 7/31/2020 AM180883A 7/31/2020 AM180884A 7/31/2020 AM180885A 7/31/2020 AM180886A 7/31/2020 AM180887A 7/31/2020 AM180888A 7/31/2020 AM180889A 7/31/2020 AM180936A 7/31/2020 AM180937A 7/31/2020 AM180938A 7/31/2020 AM180939A 7/31/2020 AM180940A 7/31/2020 AM180960A 7/31/2020 AM180961A 7/31/2020 AM180962A 7/31/2020 AM180963A 7/31/2020 AM180964A 7/31/2020 AM180965A 7/31/2020 AM180992A 7/31/2020 AM180993A 7/31/2020 AM180994A 8/31/2020 AM180995A 8/31/2020 AM180996A 8/31/2020 AM180997A 8/31/2020 AM181037A 8/31/2020 AM181038A 8/31/2020 AM181039A 8/31/2020 AM181040A 8/31/2020 AM181041A 8/31/2020 AM181079A 8/31/2020 AM181080A 8/31/2020 AM181081A 8/31/2020 AM181082A 8/31/2020 AM181083A 8/31/2020 AM181084A 8/31/2020 AM181085A 8/31/2020 AM181086A 8/31/2020 AM181087A 8/31/2020 AM181088A 8/31/2020 AM181089A 8/31/2020 AM181093A 8/31/2020 AM181094A 8/31/2020 AM181095A 8/31/2020 AM181096A 8/31/2020 AM181097A 8/31/2020 AM181098A 8/31/2020 AM181099A 8/31/2020 AM181100A 8/31/2020 AM181101A 8/31/2020 AM181102A 8/31/2020 AM181116A 8/31/2020 AM181117A 9/30/2020 AM181129A 8/31/2020 AM181130A 8/31/2020 AM181131A 8/31/2020 AM181132A 8/31/2020 AM181133A 9/30/2020 AM181134A 9/30/2020 AM181135A 9/30/2020 AM181136A 9/30/2020 AM181137A 9/30/2020 AM181138A 9/30/2020 AM181183A 9/30/2020 AM181184A 9/30/2020 AM181185A 9/30/2020 AM181186A 9/30/2020 AM181187A 9/30/2020 AM181188A 9/30/2020 AM181189A 9/30/2020 AM181190A 9/30/2020 AM181235A 9/30/2020 AM181236A 9/30/2020 AM181237A 9/30/2020 AM181238A 9/30/2020 AM181239A 9/30/2020 AM181240A 9/30/2020 AM181242A 9/30/2020 AM181243A 9/30/2020 AM181314A 10/31/2020 AM181315A 11/30/2020 AM190121B 12/31/2020 AM190122B 12/31/2020 AM190713AA 6/30/2021 AM191248A 10/31/2021 AM191249A 10/31/2021 AM200192 1/31/2022 AM200322A 2/28/2022

Quantity: N/A

Reason for recall

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Recall record

Recall number: D-1345-2020
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide
Recall initiated: 2020-05-29
Classified by FDA Center: 2020-06-25
FDA published: 2020-07-01
Recalling firm: Amneal Pharmaceuticals of New York, LLC
Firm location: Brookhaven, NY

Drug identification

Brand name(s): METFORMIN HYDROCHLORIDE
Generic name(s): METFORMIN HYDROCHLORIDE
Manufacturer(s): Amneal Pharmaceuticals LLC
NDC(s): 65162-178, 65162-179
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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