Reported Jul 1, 2020 · Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal…
Amneal Pharmaceuticals of New York, LLC
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: Amneal Pharmaceuticals of New York, LLC · 50 Horseblock Rd · Brookhaven, NY · 11719-9509
Is this the product you have?
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles
- Distributed byAmneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10
- Lot codes and dates
HF08618A6/30/2020HF08718A6/30/2020HF15418A7/31/2020HF15518A7/31/2020HH11818A9/30/2020HJ00818A9/30/2020HJ00918A9/30/2020HJ01018A9/30/2020
- Amount recalled
- N/A
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are 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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