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
Check against the official notice below — it lists the full affected range.
Amneal Pharmaceuticals of New York, LLC is recalling Amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg in 100-tablet bottles distributed nationwide. The recall was initiated because the FDA detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels in the medication due to current Good Manufacturing Practice (CGMP) deviations.
The affected lots include multiple batches with expiration dates ranging from October 2020 through December 2021, identified by lot numbers AM181337A through AM200111. The recall source does not specify what actions consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Reason for recall: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Distribution: Nationwide Quantity: N/A Lot/code info: 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
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.