Class III
Terminated
Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66
- Company
- Teva Pharmaceuticals Usa, Inc.
- Recall Initiated
- March 14, 2013
- Posted
- June 5, 2013
- Recall Number
- D-496-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 17,108 blister packs
- Firm Location
- Sellersville, PA, United States
Reason for Recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Distribution
Nationwide
Lot / Code Info
NDC 51285-058-66 -- lot numbers 33802330A, exp 6/2013; and 33802464A, exp 6/2013.
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