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Denton Pharma, Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309

Recalled November 11, 2020 · FDA recall D-0057-2021 · Denton Pharma

Hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) · FDA Class II
Units
a) 684; b) 432; c) 3668; d) 2029 bottles
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 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131
Manufacturer(s)
Denton Pharma, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Denton Pharma, Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309 | RecallWatchUSA