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
Check against the official notice below — it lists the full affected range.
Teva Pharmaceuticals USA, Inc. is recalling Junel Fe 1.5/30, a birth control medication, due to the detection of an impurity called N-Butyl-Benzene Sulfonamide (NBBS) during testing. The affected product is a 28-day regimen combining norethindrone acetate and ethinyl estradiol tablets with ferrous fumarate tablets. Approximately 47,200 blister packs were distributed nationwide across four specific lot numbers with expiration dates ranging from April to May 2013.
The affected lot numbers are 33802123A (expiring 4/2013), 33802202A (expiring 5/2013), 33802203A (expiring 5/2013), and 33802204A (expiring 5/2013), all carrying NDC 0555-9028-58. The source document does not specify what consumers should do regarding this 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: 47,200 blister packs Lot/code info: NDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.