Reported Jul 1, 2020 · Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC…
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, Bulk, Rx Only
- Distributed byAmneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
- Lot codes and dates
HA01520A1/31/2021HA01620A1/31/2021HG01719A7/31/2020HG01819A7/31/2020HH09319A8/31/2020HH09419A9/30/2020HK07619A10/31/2020HK07719A10/31/2020
- 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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