Drug product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-832-25; Blister NDC 68084-832-95
D-1488-2016
Product summary
- Event
- Event 75076
- Status
- Terminated
- Classification
- Class II
- Quantity
- 666 cartons
- Official record key
drug-enforcement:D-1488-2016
Official wording
Reason: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Code information: Lot 152325, exp. 12/31/16, lot 154834, exp. 5/31/17
Distribution pattern: Product was distributed in the following states: Nationwide
Derived failure modes
-
Labeling or packaging
Mispackaging