Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-Release Tablets USP 500 mg in 60-count bottles distributed throughout the United States. The FDA detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level in the product, which represents a current good manufacturing practice (CGMP) deviation. A total of 59,568 bottles are affected across multiple batches manufactured between August 2020 and February 2022.
The affected lot numbers are: G808293, G808284, G808285, G808343 (August 2020); G901201, G901202 (December 2020); G906915, G906913, G906914 (July 2021); and G002135 (January 2022) and G002849 (February 2022). The source does not specify a remedy or corrective action for affected consumers.
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: 59,568 bottles Lot/code info: Batch # G808293 Aug-20 G808284 Aug-20 G808285 Aug-20 G808343 Aug-20 G901201 Dec-20 G901202 Dec-20 G906915 Jul-21 G906913 Jul-21 G906914 Jul-21 G002135 Jan-22 G002849 Feb-22
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.