Drug product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.
D-0566-2016
Product summary
- Event
- Event 72988
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,717 bottles
- Official record key
drug-enforcement:D-0566-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Code information: Lot #: 34015516A, Exp 05/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification