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
Check against the official notice below — it lists the full affected range.
Teva Pharmaceuticals USA, Inc. is recalling Lessina (levonorgestrel and ethinyl estradiol tablets) 0.1 mg/0.02 mg in 28-day regimens due to the detection of an impurity called N-Butyl-Benzene Sulfonamide (NBBS) during testing. The affected product was distributed nationwide and includes 148,785 blister packs across four specific lot numbers with expiration dates ranging from August 2013 to March 2014.
The source document does not specify what consumers who have this medication should do regarding the recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Reason for recall: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Distribution: Nationwide distribution. No foreign or government accounts. Quantity: 148,785 blister packs Lot/code info: NDC 0555-9014-67, Lot numbers 33802921A, exp 8/2013; 33803173A, exp 10/2013; 33803695A, exp 2/2014; and 33803942A, exp 3/2014.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.