FDA Recall D-1349-2020

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, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10

Lot / code: AM181337A 10/31/2020 AM181338A 10/31/2020 AM181339A 11/30/2020 AM181340A 11/30/2020 AM181341A 11/30/2020 AM181342A 11/30/2020 AM181343A 11/30/2020 AM181344A 11/30/2020 AM181356A 11/30/2020 AM181357A 11/30/2020 AM181358A 11/30/2020 AM181359A 11/30/2020 AM181360A 11/30/2020 AM181361A 11/30/2020 AM181362A 11/30/2020 AM181363A 11/30/2020 AM181415A 11/30/2020 AM190040B 12/31/2020 AM190041A 12/31/2020 AM190042A 12/31/2020 AM190043A 12/31/2020 AM190044A 12/31/2020 AM190045A 12/31/2020 AM190046A 12/31/2020 AM190473B 4/30/2021 AM190474A 4/30/2021 AM190475A 4/30/2021 AM190476A 4/30/2021 AM190477A 4/30/2021 AM190478A 4/30/2021 AM190479A 4/30/2021 AM190480A 4/30/2021 AM190481A 4/30/2021 AM190482A 4/30/2021 AM190834A 7/31/2021 AM190835A 7/31/2021 AM190836A 7/31/2021 AM190837A 7/31/2021 AM190838A 7/31/2021 AM191004A 8/31/2021 AM191005A 8/31/2021 AM191006A 8/31/2021 AM191007A 8/31/2021 AM191008A 9/30/2021 AM191271A 10/31/2021 AM191272A 10/31/2021 AM191273A 10/31/2021 AM191274A 10/31/2021 AM191338A 11/30/2021 AM191339A 11/30/2021 AM191340A 11/30/2021 AM191341 12/31/2021 AM191342 12/31/2021 AM200109 12/31/2021 AM200110 12/31/2021 AM200111 12/31/2021

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-1349-2020
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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