Recalls / Class III
Class IIID-681-2013
Product
Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67
- Brand name
- Lessina
- Generic name
- Levonorgestrel And Ethinyl Estradiol
- NDC
- 0555-9014
- FDA application
- ANDA075803
- Affected lot / code info
- NDC 0555-9014-67, Lot numbers 33802921A, exp 8/2013; 33803173A, exp 10/2013; 33803695A, exp 2/2014; and 33803942A, exp 3/2014.
Why it was recalled
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 148,785 blister packs
- Distribution pattern
- Nationwide distribution. No foreign or government accounts.
Timeline
- Recall initiated
- 2013-03-15
- FDA classified
- 2013-07-05
- Posted by FDA
- 2013-07-17
- Terminated
- 2014-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-681-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.