drugs Class III Updated 2013-07-17

Teva Pharmaceuticals USA, Inc. recalls Balziva(TM) (norethindrone and ethinyl estradiol tablets, US

Recalled Product

Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58

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 0555-9034-58, Lot numbers 33802100A, exp 3/2013; 33802266A, exp 3/2013; and 33802832A, exp 8/2013.
View official government recall

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