PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 2, 2014 Initiated: May 1, 2014 #D-1408-2014

Product Description

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.

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
9,882 bottles
Distribution
Nationwide and Puerto Rico
Location
Horsham, PA

Frequently Asked Questions

What product was recalled?
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.. Recalled by Teva Pharmaceuticals USA. Units affected: 9,882 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 2, 2014. Severity: Moderate. Recall number: D-1408-2014.