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 05

FDA recall notice · announced January 20, 2016 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lot #: 34015516A, Exp 05/16
Quantity: 9,717 bottles
Status: Terminated
Products in this recall event:
- 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, T (D-0566-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.