drugs Class III Updated 2013-07-17

Teva Pharmaceuticals USA, Inc. recalls Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0

Recalled Product

Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: NDC 0555-9123-66, Lot numbers 33802986A, exp 9/2013; 33802991A, exp 7/2013; and 33803270A, exp 10/2013.
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