Drug product
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
D-0323-2024
Product summary
- Event
- Event 93786
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4,662 bottles
- Official record key
drug-enforcement:D-0323-2024
Official wording
Reason: Labeling: Label Mix-up
Code information: Lot # F230169A, Exp. 06/30/2025
Distribution pattern: USA nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up