Reported Jul 1, 2020 · Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 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, 750 mg, Rx only, 100 Tablets bottles
- Manufactured byAmneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213
- INDIA Distributed byAmneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10
- Lot codes and dates
112 of 112 codes
AM181337A10/31/2020AM181338A10/31/2020AM181339A11/30/2020AM181340A11/30/2020AM181341A11/30/2020AM181342A11/30/2020AM181343A11/30/2020AM181344A11/30/2020AM181356A11/30/2020AM181357A11/30/2020AM181358A11/30/2020AM181359A11/30/2020AM181360A11/30/2020AM181361A11/30/2020AM181362A11/30/2020AM181363A11/30/2020AM181415A11/30/2020AM190040B12/31/2020AM190041A12/31/2020AM190042A12/31/2020AM190043A12/31/2020AM190044A12/31/2020AM190045A12/31/2020AM190046A12/31/2020AM190473B4/30/2021AM190474A4/30/2021AM190475A4/30/2021AM190476A4/30/2021AM190477A4/30/2021AM190478A4/30/2021
- 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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