RecallDepth
Class II Terminated

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.

Company
Teva Pharmaceuticals Usa
Recall Initiated
October 8, 2014
Posted
November 5, 2014
Recall Number
D-0050-2015
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
19,545 Bottles
Firm Location
Horsham, PA, United States

Reason for Recall

Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.

Distribution

U.S. Nationwide including Puerto Rico.

Lot / Code Info

Lot #: 34016373A, Expiry: 7/2016; Lot #: 34016377A, Expiry: 7/2016.

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