FDA recall D-1438-2014

Teva Pharmaceuticals USA · Class III · drug

Product

Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58

Reason for recall

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-06-17
Report date: 2014-07-23
Termination date: 2015-03-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1438-2014