FDA Recall D-1344-2020

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 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08907 NDC 65162-178-09

Lot / code: AM190123A 1/31/2021 AM190193A 1/31/2021 AM190194A 1/31/2021 AM190195A 1/31/2021 AM190196A 1/31/2021 AM190197A 1/31/2021 AM190198A 1/31/2021 AM190199A 1/31/2021 AM190200A 2/28/2021 AM190201A 2/28/2021 AM190202A 2/28/2021 AM190269A 2/28/2021 AM190270A 2/28/2021 AM190271A 2/28/2021 AM190272A 2/28/2021 AM190289A 2/28/2021 AM190290A 2/28/2021 AM190291A 2/28/2021 AM190292A 2/28/2021 AM190293A 2/28/2021 AM190294A 2/28/2021 AM190549A 4/30/2021 AM190550A 4/30/2021 AM190551A 4/30/2021 AM190552A 4/30/2021 AM190553A 4/30/2021 AM190554A 4/30/2021 AM190555A 5/31/2021 AM190556A 5/31/2021 AM190586A 5/31/2021 AM190587A 5/31/2021 AM190588A 5/31/2021 AM190589A 5/31/2021 AM190590A 5/31/2021 AM190605A 5/31/2021 AM190673A 6/30/2021 AM190707A 6/30/2021 AM190708A 6/30/2021 AM190709A 6/30/2021 AM190710A 6/30/2021 AM190714C 6/30/2021 AM190751C 6/30/2021 AM190752C 6/30/2021 AM190753A 8/31/2021 AM190754A 8/31/2021 AM190755A 8/31/2021 AM190756A 8/31/2021 AM190757A 8/31/2021 AM190929A 8/31/2021 AM190930A 8/31/2021 AM190931A 8/31/2021 AM190932A 8/31/2021 AM190933A 8/31/2021 AM190995A 8/31/2021 AM191000A 8/31/2021 AM191001A 8/31/2021 AM191002A 8/31/2021 AM191003A 8/31/2021 AM191034A 9/30/2021 AM191035A 9/30/2021 AM191036A 9/30/2021 AM191037A 9/30/2021 AM191038A 9/30/2021 AM191039A 9/30/2021 AM191086A 9/30/2021

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-1344-2020
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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