Metformin Hydrochloride Extended-Release Tablets recalled over manufacturing violations

Recall date

October 8, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0057-2021

FDA classification

Class II

Brand / firm

Denton Pharma, Inc.

Sold / distributed

Indiana - Nationwide.

Why it was recalled

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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