Drug product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-898-32; Blister NDC 68084-898-33
D-1487-2016
Product summary
- Event
- Event 75076
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126 cartons
- Official record key
drug-enforcement:D-1487-2016
Official wording
Reason: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Code information: Lot 162489, exp. 9/30/17 and lot 162910, exp. 10/31/17
Distribution pattern: Product was distributed in the following states: Nationwide
Derived failure modes
-
Labeling or packaging
Mispackaging