Reported Jul 1, 2020 · Ongoing
amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured 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 Rx Only 90 Tablets bottles
- Manufactured byAmneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213
- INDIA Distributed byAmneal Pharmaceuticals LLC Bridgewater, NJ 08907 NDC 65162-178-09
- Lot codes and dates
130 of 130 codes
AM190123A1/31/2021AM190193A1/31/2021AM190194A1/31/2021AM190195A1/31/2021AM190196A1/31/2021AM190197A1/31/2021AM190198A1/31/2021AM190199A1/31/2021AM190200A2/28/2021AM190201A2/28/2021AM190202A2/28/2021AM190269A2/28/2021AM190270A2/28/2021AM190271A2/28/2021AM190272A2/28/2021AM190289A2/28/2021AM190290A2/28/2021AM190291A2/28/2021AM190292A2/28/2021AM190293A2/28/2021AM190294A2/28/2021AM190549A4/30/2021AM190550A4/30/2021AM190551A4/30/2021AM190552A4/30/2021AM190553A4/30/2021AM190554A4/30/2021AM190555A5/31/2021AM190556A5/31/2021AM190586A5/31/2021
- 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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