FDAFDA · Food and drugs·Recall number D-681-2013
Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67
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
- LESSINA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Distributor
- Nationwide distribution. No foreign or government accounts.
- Lot
- NDC 0555-9014-67, Lot numbers 33802921A, exp 8/2013; 33803173A, exp 10/2013; 33803695A, exp 2/2014; and 33803942A, exp 3/2014.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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