Product Detail

Product Description Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66

Recall Number D-683-2013

Classification Class III

Code Info NDC 0555-9123-66, Lot numbers 33802986A, exp 9/2013; 33802991A, exp 7/2013; and 33803270A, exp 10/2013.

Product Distributed Qty 54,412 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