Recalls / Class III
Class IIID-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
- Brand name
- Velivet
- Generic name
- Desogestrel And Ethinyl Estradiol
- NDC
- 0555-9051
- FDA application
- ANDA076455
- Affected lot / code info
- Lot 33805449A, Exp. 12/14
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 5265 blister packs
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-06-17
- FDA classified
- 2014-07-17
- Posted by FDA
- 2014-07-23
- Terminated
- 2015-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1439-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.