Drug recall D-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
Reason for recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Lots and codes
NDC 0555-9014-67, Lot numbers 33802921A, exp 8/2013; 33803173A, exp 10/2013; 33803695A, exp 2/2014; and 33803942A, exp 3/2014.
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc., Sellersville, PA
- Quantity
- 148,785 blister packs
- Distribution
- Nationwide distribution. No foreign or government accounts.
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2013
- Terminated
- April 10, 2014
Related products
- Lessina – drug information
- NDC 0555-9014 Lessina · · Teva Pharmaceuticals USA, Inc.