Alembic Pharmaceuticals Limited is recalling 4,884 bottles of Fesoterodine Fumarate Extended-release Tablets (4 mg) because testing found levels of an impurity called 'Diester' that exceed the allowed safety specifications. Fesoterodine Fumarate is a prescription medication used to treat overactive bladder. The recall affects 30-count bottles distributed nationwide across the United States. Consumers should consult their healthcare provider or pharmacist regarding the use of this medication.
The product contains levels of a chemical impurity that exceed approved safety limits, which may lead to degradation of the drug's quality or unintended health effects over time.
You have 2 options:
Rx only; Manufactured by Alembic Pharmaceuticals Limited, India.
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Sources: FDA iRES · Raw API Response
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