Drug recall D-1408-2014

Class II Terminated reported Jul 2, 2014

Product

Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.

Reason for recall

Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.

Lots and codes

Lot # 34013122A, Exp 11/15

Recall details

Recalling firm
Teva Pharmaceuticals USA, Horsham, PA
Quantity
9,882 bottles
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
May 1, 2014
Terminated
December 9, 2014

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