Drug product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-936-25; Blister NDC 68084-936-95
D-1482-2016
Product summary
- Event
- Event 75076
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,276 cartons
- Official record key
drug-enforcement:D-1482-2016
Official wording
Reason: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Code information: Lot 150130, exp. 10/31/16 and lot 161296, exp. 8/31/17
Distribution pattern: Product was distributed in the following states: Nationwide
Derived failure modes
-
Labeling or packaging
Mispackaging