Recalls / Class III
Class IIID-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
- Affected lot / code info
- Lot 33805507A, Exp. date 11/14
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 984 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-1437-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.