Drug product
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.
D-0925-2023
Product summary
- Event
- Event 92667
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2652 bottles
- Official record key
drug-enforcement:D-0925-2023
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot 22122841, Exp August 2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications