FDA recall D-1439-2014

Product

Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67

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-1439-2014