Drug product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.
D-0660-2026
Product summary
- Event
- Event 99319
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1392 bottles
- Official record key
drug-enforcement:D-0660-2026
Official wording
Reason: Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Code information: Lot#: 25285401A, Exp. Date: 04/2027
Distribution pattern: US Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up