Drug 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
D-0156-2026
Product summary
- Event
- Event 97812
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 4,884 30-count bottles
- Official record key
drug-enforcement:D-0156-2026
Official wording
Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Code information: Lot # 2405006633, Exp Date: 03/31/2026
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications