Teva Pharmaceuticals USA, Inc. recalls Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-C
Recalled June 5, 2013 · FDA recall D-497-2013 · Teva Pharmaceuticals USA
Hazard
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing · FDA Class III
Units
120,049 blister packs
Sold at
Nationwide
Description
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Product
Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA
Manufacturer(s)
Teva Pharmaceuticals USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →