Drug product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 60687-133-25; Blister NDC 60687-133-95
D-1483-2016
Product summary
- Event
- Event 75076
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,416 cartons
- Official record key
drug-enforcement:D-1483-2016
Official wording
Reason: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Code information: Lot 150950, exp. 3/31/17 and lot 154813, exp. 5/31/2017
Distribution pattern: Product was distributed in the following states: Nationwide
Derived failure modes
-
Labeling or packaging
Mispackaging