Drug product
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
D-0248-2026
Product summary
- Event
- Event 98119
- Status
- Ongoing
- Classification
- Class III
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0248-2026
Official wording
Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Code information: Lot# 2405003360, Exp Date: Jan 31, 2026
Distribution pattern: US Nationwide and PR.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications