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

FDA recall notice · announced July 2, 2014 · Teva Pharmaceuticals

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

The 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.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot # 34013122A, Exp 11/15
Quantity: 9,882 bottles
Status: Terminated
Products in this recall event:
- Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02. (D-1408-2014)

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