Reported Jun 24, 2020 · Terminated
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC…
AVKARE 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: AVKARE Inc. · 615 N 1st St · Pulaski, TN · 38478-2403
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 90 count (NDC 42291-611-90) |
| 2 | 180 count (NDC 42291-611-18) |
| 3 | 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 23069 Exp. 11/30/2020, 24571 Exp. 05/31/2021, 25310 Exp. 07/31/2021, 26391 Exp. 01/31/2022 2 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 3 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 - Amount recalled
- 88,545 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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