FDA recall D-1437-2014

Product

Mircette (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, USA, Sellersville, PA. NDC 51285-114-58

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-1437-2014