Drug product
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
D-0304-2025
Product summary
- Event
- Event 96416
- Status
- Terminated
- Classification
- Class III
- Quantity
- 224 cartons
- Official record key
drug-enforcement:D-0304-2025
Official wording
Reason: Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Code information: Lot# T05393, Exp. Date: 09/30/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification