Product Detail

Product Description Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58

Recall Number D-684-2013

Classification Class III

Code Info NDC 0555-9034-58, Lot numbers 33802100A, exp 3/2013;
33802266A, exp 3/2013; and 33802832A, exp 8/2013.

Product Distributed Qty 36,708 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 FirmTeva 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
accounts.