Teva Pharmaceuticals USA, Inc. recalls Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regi
Recalled July 17, 2013 · FDA recall D-682-2013 · Teva Pharmaceuticals USA
Hazard
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing · FDA Class III
Units
47,200 blister packs
Sold at
Nationwide distribution. No foreign or government accounts.
Description
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Product
Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58
Manufacturer(s)
Teva Pharmaceuticals USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →