Class III
Terminated
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
- Company
- Teva Pharmaceuticals Usa, Inc.
- Recall Initiated
- March 15, 2013
- Posted
- July 17, 2013
- Recall Number
- D-681-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 148,785 blister packs
- Firm Location
- Sellersville, PA, United States
Reason for Recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Distribution
Nationwide distribution. No foreign or government accounts.
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.
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