FDA-Drug2025-11-26Class III
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
Alembic Pharmaceuticals Limited
Hazard
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Sold states
Nationwide in the USA.
Affected count
4,884 30-count bottles
Manufactured in
Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, Panchmahal, India
Products
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0156-2026Don't want to check this manually?
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