FDA-Drug2026-01-14Class III
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
Alembic Pharmaceuticals Limited
Hazard
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Sold states
US Nationwide and PR.
Manufactured in
Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, Panchmahal, India
Products
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0248-2026Don't want to check this manually?
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