Drug product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.
D-0050-2015
Product summary
- Event
- Event 69483
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,545 Bottles
- Official record key
drug-enforcement:D-0050-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Code information: Lot #: 34016373A, Expiry: 7/2016; Lot #: 34016377A, Expiry: 7/2016.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out of specification