drugs Class III Updated 2013-07-17

Teva Pharmaceuticals USA, Inc. recalls Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, US

Recalled Product

Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67


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 0555-9014-67, Lot numbers 33802921A, exp 8/2013; 33803173A, exp 10/2013; 33803695A, exp 2/2014; and 33803942A, exp 3/2014.
View official government recall

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