Marksans Pharma Limited recalls Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured
Recalled November 11, 2020 · FDA recall D-0062-2021 · Marksans Pharma
Hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level · FDA Class II
Units
368,976 bottles
Sold at
Nationwide
Description
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product
Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01
Manufacturer(s)
Marksans Pharma Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →