Drug product
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
D-0112-2025
Product summary
- Event
- Event 95630
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1608 bottles
- Official record key
drug-enforcement:D-0112-2025
Official wording
Reason: Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Code information: Lot: 23274856A, Exp 04/30/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications