drugs Class III Updated 2013-06-05

Teva Pharmaceuticals USA, Inc. recalls Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.1

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: NDC 51285-058-66 -- lot numbers 33802330A, exp 6/2013; and 33802464A, exp 6/2013.
View official government recall

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