Drug product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-281-10
D-0047-2021
Product summary
- Event
- Event 86584
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6780 bottles
- Official record key
drug-enforcement:D-0047-2021
Official wording
Reason: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Code information: Lot: 19T16 Exp. Jan. 2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect