Metformin Hydrochloride Extended-Release Tablets USP 750 mg 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 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackage…
- Recall number
- D-0056-2021
- 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 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
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