Reported Jun 24, 2020 · Completed
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc.…
Apotex Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Inc. · 150 Signet Drive · North York · N/A
Is this the product you have?
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles
- Rx Only Manufactured byApotex, Inc. Toronto
- Ontario Canada M9L 1T9 Manufactured forApotex Corp. Weston, Florida 33326 NDC 60505-0260-1
- Lot codes and dates
- All lots remaining within expiry
- Amount recalled
- 305,963 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
This product could cause temporary or reversible health problems — stop using it.
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