Marksans Pharma Limited recalls Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactur
Recalled July 1, 2020 · FDA recall D-1356-2020 · Marksans Pharma
Hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level · FDA Class II
Units
11279 bottles
Sold at
Nationwide
Description
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, 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 Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01
Manufacturer(s)
Marksans Pharma Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →