FDA-Drug2020-07-01Class II
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 by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Teva Pharmaceuticals USA
Hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Sold states
Product was distributed throughout the United States, including Puerto Rico.
Affected count
a) 92,793 bottles and b) 4,824 bottles
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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 by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1331-2020Don't want to check this manually?
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