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Alembic Pharmaceuticals Limited: Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 3

DrugsSource: FDA (drug) · Date: 2025-11-26

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Alembic Pharmaceuticals Limited
Product
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
Reason / hazard
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Classification
Class III
Status
Ongoing
Distribution / sold at
Nationwide in the USA.
Recall initiated
2025-10-10
Code info
Lot # 2405006633, Exp Date: 03/31/2026
Product quantity
4,884 30-count bottles
Voluntary mandated
Voluntary: Firm initiated
City
Panchmahal
Country
India
Event id
97812
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