Product Detail

Product Description Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.

Recall Number D-246-2013

Classification Class III

Code Info Lot #: 33803603A, 33803604A, Exp 11/13; 33803996A, and 33803997A, Exp 03/14

Product Distributed Qty 71,893 dispensers

Reason For Recall Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.

Event Detail

Event Id 64607

Product Type Drugs

Status Ongoing

Recalling Firm Teva Pharmaceuticals USA, Inc. Sellersville, PA, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-03-12

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide