Reported Jul 1, 2020 · Ongoing
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by:…
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 Rx Only, 500 Tablets bottles
- Manufactured byAmneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213
- INDIA Distributed byAmneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-50
- Lot codes and dates
194 of 194 codes
AM180641A6/30/2020AM180642A6/30/2020AM180643A6/30/2020AM180644A6/30/2020AM180645A6/30/2020AM180646A6/30/2020AM180647A6/30/2020AM180880A7/31/2020AM180881A7/31/2020AM180882A7/31/2020AM180883A7/31/2020AM180884A7/31/2020AM180885A7/31/2020AM180886A7/31/2020AM180887A7/31/2020AM180888A7/31/2020AM180889A7/31/2020AM180936A7/31/2020AM180937A7/31/2020AM180938A7/31/2020AM180939A7/31/2020AM180940A7/31/2020AM180960A7/31/2020AM180961A7/31/2020AM180962A7/31/2020AM180963A7/31/2020AM180964A7/31/2020AM180965A7/31/2020AM180992A7/31/2020AM180993A7/31/2020
- 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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