FDAFDA · Food and drugs·Recall number D-1303-2020
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
Published June 24, 2020 · Recall initiated: May 27, 2020
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Apotex Inc.
- Distributor
- Nationwide.
- Lot
- All lots remaining within expiry
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
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