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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Product Detail

Product Description Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
Recall Number D-1384-2012
Classification Class III
Code Info Lot #'s 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013
Product Distributed Qty 40,750 Dispensers
Reason For Recall Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.

Event Detail

Event Id 61759
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 2012-04-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide