FDA recall D-0050-2015

Teva Pharmaceuticals USA · Class II · drug

Product

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.

Distribution

U.S. Nationwide including Puerto Rico.

Key facts

Status: Terminated
Initiation date: 2014-10-08
Report date: 2014-11-05
Termination date: 2015-09-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0050-2015