FDA recall D-1436-2014

Teva Pharmaceuticals USA · Class III · drug

Product

Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58

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-1436-2014