Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1

FDA recall notice · announced June 24, 2020 · Apotex

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1

Reason for recall

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels

Notes

Distribution: Nationwide.
Lot/code information: All lots remaining within expiry
Quantity: 305,963 bottles
Status: Completed
Products in this recall event:
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33 (D-1303-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.