Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals is recalling 64,344 bottles of Metformin Hydrochloride Extended-release Tablets USP 500 mg that were distributed throughout the United States. The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity in the product at levels above the acceptable intake level, which represents a deviation from good manufacturing practices. The affected product was manufactured by Lupin Limited in Goa and includes 20 specific batch numbers produced between August 2020 and February 2022.
The record does not specify a remedy or recommended action for consumers who have this medication.
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: Product was distributed throughout the United States. Quantity: 64,344 bottles Lot/code info: Batch# G808201 Aug-20 G808202 Aug-20 G808200 Aug-20 G900935 Dec-20 G901311 Dec-20 G900957 Dec-20 G900958 Dec-20 G901006 Dec-20 G904803 May-21 G904804 May-21 G906551 Jul-21 G906552 Jul-21 G907375 Aug-21 G908605 Oct-21 G908604 Oct-21 G002108 Jan-22 G002109 Jan-22 G002559 Feb-22 G002560 Feb-22
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.