Drug product
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
D-0599-2025
Product summary
- Event
- Event 97397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8544 bottles
- Official record key
drug-enforcement:D-0599-2025
Official wording
Reason: Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Code information: Lot #: 25280726A, Exp. Date 03/2027
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up