Reported Jul 1, 2020 · Ongoing
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 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, 100 Tablets bottles
- Manufactured byAmneal Pharmaceuticals Pvt. Ltd
- Ahmedabad 382213 India Distributed byAmneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-10
- Lot codes and dates
360 of 360 codes
AM181118AA10/31/2020AM181191AA9/30/2020AM181192AA9/30/2020AM181235AA9/30/2020AM181236AA9/30/2020AM181237AA9/30/2020AM181240AA9/30/2020AM181241AA9/30/2020AM181242AA9/30/2020AM181243AA9/30/2020AM181244AA10/31/2020AM181268AA10/31/2020AM181269AA10/31/2020AM181270AA10/30/2020AM181271AA10/31/2020AM181272AA10/31/2020AM181273AA10/31/2020AM181274AA10/31/2020AM181275AA10/31/2020AM181276AA10/31/2020AM181277AA10/31/2020AM181307AA10/31/2020AM181308AA10/31/2020AM181309AA10/31/2020AM181310AA10/31/2020AM181311AA10/31/2020AM181313AA10/31/2020AM181314AA10/31/2020AM181315AA11/30/2020AM181316AA11/30/2020
- 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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