Product Detail
Product Description 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
Recall Number D-681-2013
Classification Class III
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.

Product Distributed Qty 148,785 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
accounts.