Reported Jul 1, 2020 · Terminated
Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC…
Teva Pharmaceuticals USA
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: Teva Pharmaceuticals USA · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
- Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only
- Manufactured byWatson Pharma Private Limited, Verna, Salcette Goa
- Distributed byActavis Pharma, Inc., Parsippany, NJ
- Lot codes and dates
a) 1329548Aexp. date 06/2020 1338302Mexp. date 10/2020 1348968Mexp. date 10/2020 1348969Mexp. date 10/2020 1348970Mexp. date 11/2020 1376339Mexp. date 09/2021 b) 1323460Mexp. date 06/2020 1330919Mexp. date 6/2020 1338300Aexp. date 10/2020 1341135Mexp. date 12/2020 1391828Mexp. date 11/2021
- Amount recalled
- a) 92,793 bottles and b) 4,824 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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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