Product Detail

Product Description 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

Recall Number D-682-2013

Classification Class III

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.

Product Distributed Qty 47,200 blister packs

Reason For Recall Failed Impurity/Degradation Specification; an impurity
identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during
impurity testing

Event Detail

Event Id 64644

Product Type Drugs

Status Ongoing

Recalling Firm
Teva Pharmaceuticals USA, Inc.
City Sellersville
State PA
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-03-15

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide distribution. No foreign or government