FDAFDA · Food and drugs·Recall number D-1360-2020
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
Published July 8, 2020 · Recall initiated: June 12, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Harvard Drug Group
- Distributor
- Nationwide USA
- Lot
- Lot T-02134, exp 09/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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