drugs Class III Updated 2013-06-05

Teva Pharmaceuticals USA, Inc. recalls Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: NDC 0555-3134-82 and 0093-3134-91 -- lot numbers 33802566A, exp 3/2013; 33802967A, exp 8/2013; 33803529A, exp 10/2013; and 33803609A, exp 11/2013.
View official government recall

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