Teva Pharmaceuticals USA, Inc. recalls Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets
Recalled June 5, 2013 · FDA recall D-496-2013 · Teva Pharmaceuticals USA
Hazard
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing · FDA Class III
Units
17,108 blister packs
Sold at
Nationwide
Description
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
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
Manufacturer(s)
Teva Pharmaceuticals USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →