FDAFDA · Food and drugs·Recall number D-1304-2020
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Published June 24, 2020 · Recall initiated: June 4, 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 Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AVKARE Inc.
- Distributor
- Nationwide.
- Lot
- Lots: a) 23069 Exp. 11/30/2020, 24571 Exp. 05/31/2021, 25310 Exp. 07/31/2021, 26391 Exp. 01/31/2022; b) 22542 Exp. 06/30/2020, 23345 Exp. 11/30/2020, 24032 Exp. 03/31/2021, 24624 Exp. 07/31/2021, 24631 Exp. 05/31/2021, 25381 Exp. 08/31/2021, 25907 Exp. 10/31/2021, 26478 Exp. 01/31/2022; c) 22348 Exp. 06/30/2020, 22405 Exp. 06/30/2020, 22406 Exp. 06/30/2020, 22740 Exp. 06/30/2020, 23346 Exp. 11/30/2020, 23926 Exp. 03/31/2021, 24364 Exp. 05/31/2021, 25014 Exp. 07/31/2021, 25334 Exp. 09/30/2021, 25906 Exp. 10/31/2021, 26392 Exp. 01/31/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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