Drug recall D-682-2013
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
Reason for recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Lots and codes
NDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013.
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc., Sellersville, PA
- Quantity
- 47,200 blister packs
- Distribution
- Nationwide distribution. No foreign or government accounts.
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2013
- Terminated
- April 10, 2014
Related products
- Junel – drug information
- NDC 0555-9027 Junel 21 Day · Norethindrone Acetate 1.5 mg/1; Ethinyl Estradiol 30 ug/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0555-9025 Junel 21 Day · Norethindrone Acetate 1 mg/1; Ethinyl Estradiol 20 ug/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0555-9028 Junel Fe 28 Day · · Teva Pharmaceuticals USA, Inc.
- NDC 0555-9026 Junel Fe 28 Day · · Teva Pharmaceuticals USA, Inc.