Denton Pharma, Inc. recalls Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged
Recalled November 11, 2020 · FDA recall D-0056-2021 · Denton Pharma
Hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) · FDA Class II
Units
N/A
Sold at
Indiana - Nationwide.
Description
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Product
Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
Manufacturer(s)
Denton Pharma, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →