Product Detail

Product Description Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58

Recall Number D-689-2013

Classification Class III

Code Info Lot #s: 33801773A, Exp 7/14; 33801774A, Exp 8/14;
33801775A, 33801776A, Exp 9/14; 33802427A, 33802428A, 33802429A, 33802430A, Exp 12/14; 33802925A, 33802926A, Exp 3/15; 33803383A, 33803384A, 33803385A, 33803387A, 33803685A, Exp 6/15.

Product Distributed Qty 154,536 cartons

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 64643

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