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
Reported: July 8, 2020 Initiated: June 12, 2020 #D-1360-2020
Product Description
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
Reason for Recall
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Details
- Recalling Firm
- The Harvard Drug Group
- Units Affected
- 1,906 Cartons
- Distribution
- Nationwide USA
- Location
- Livonia, MI
Frequently Asked Questions
What product 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. Recalled by The Harvard Drug Group. Units affected: 1,906 Cartons.
Why was this product recalled? ▼
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 8, 2020. Severity: Moderate. Recall number: D-1360-2020.
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