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

Recall Number: D-496-2013

Firm: Teva Pharmaceuticals USA, Inc.

Classification: Class III

Status: Terminated

Report Date: 20130605

Initiation Date: 20130314

Termination Date: 20140115

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

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