Recall: D-0566-2016

Class II - Potentially Harmful

Class IIClassification

2015-11-12Initiated

TerminatedStatus

Teva Pharmaceuticals USAFirm

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.

Reason

Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.