Metformin Hydrochloride Extended-Release Tablets recalled over manufacturing violations
- Recall date
- June 12, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- The Harvard Drug Group recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufa…
- Recall number
- D-1360-2020
- FDA classification
- Class II
- Brand / firm
- The Harvard Drug Group
- Sold / distributed
- Nationwide USA
Why it was recalled
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
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, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61
Get recall alerts
Free email alert whenever The Harvard Drug Group has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: The Harvard Drug Group