Teva Pharmaceuticals USA, Inc. recalls Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva
Recalled July 17, 2013 · FDA recall D-689-2013 · 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
154,536 cartons
Sold at
Nationwide and Puerto Rico
Description
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Product
Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58
Manufacturer(s)
Teva Pharmaceuticals USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →