FDAFDA · Food and drugs·Recall number D-682-2013
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
Published July 17, 2013 · Recall initiated: March 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- JUNEL
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Distributor
- Nationwide distribution. No foreign or government accounts.
- Lot
- NDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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