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04-18-2013, 12:07 PM #1
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Recall, Birth Control: Jolessa (levonorgestrel/ethinyl estradiol) Tabs 0.15/0.03mg
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
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