Drug recall D-0050-2015
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.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Lots and codes
Lot #: 34016373A, Expiry: 7/2016; Lot #: 34016377A, Expiry: 7/2016.
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Horsham, PA
- Quantity
- 19,545 Bottles
- Distribution
- U.S. Nationwide including Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 8, 2014
- Terminated
- September 21, 2015
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