FDA recall D-1408-2014

Teva Pharmaceuticals USA · Class II · drug

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-05-01
Report date: 2014-07-02
Termination date: 2014-12-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1408-2014