Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets USP 1000 mg in 90 count bottles distributed throughout the United States. The recall was issued because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level in the product, which represents a deviation from current Good Manufacturing Practice (CGMP) standards. A total of 95,886 bottles are affected, with specific batch numbers ranging from July 2020 through February 2022.
The affected lot numbers include batches G807093, G807147, G807208, G807479, G807480, G807830, G807092, G809471, G808155, G808074, G808115, G900231, G900232, G903277, G903278, G903279, G903280, G903281, G903818, G904048, G904164, G906548, G907239, G907255, G907256, G907263, G001802, G001804, G001803, G001805, G001806, G001807, G001808, G808154, G900227, G900228, G900229, G900230, G906549, G906550, G906547, G907279, G907364, G001809, G001801, G002563, and G002564. The source document does not specify what actions affected consumers should take.
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: 95,886 bottles Lot/code info: Batch # G807093 Jul-20 G807147 Jul-20 G807208 Jul-20 G807479 Jul-20 G807480 Jul-20 G807830 Jul-20 G807092 Jul-20 G809471 Jul-20 G808155 Aug-20 G808074 Aug-20 G808115 Aug-20 G900231 Nov-20 G900232 Nov-20 G903277 Mar-21 G903278 Mar-21 G903279 Mar-21 G903280 Mar-21 G903281 Mar-21 G903818 Apr-21 G904048 Apr-21 G904164 Apr-21 G906548 Jul-21 G907239 Aug-21 G907255 Aug-21 G907256 Aug-21 G907263 Aug-21 G001802 Jan-22 G001804 Jan-22 G001803 Jan-22 G001805 Jan-22 G001806 Jan-22 G001807 Jan-22 G001808 Jan-22 G808154 Aug-20 G900227 Nov-20 G900228 Nov-20 G900229 Nov-20 G900230 Nov-20 G906549 Jul-21 G906550 Jul-21 G906547 Jul-21 G907279 Aug-21 G907364 Aug-21 G001809 Jan-22 G001801 Jan-22 G002563 Feb-22 G002564 Feb-22
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.