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U.S. Department of Health and Human Services

Enforcement Report - Week of July 5, 2012

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Product Detail

Product Description Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs
Recall Number D-1397-2012
Classification Class II
Code Info Lot #'s 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, Exp 8/2013
Product Distributed Qty 100,761 cartons
Reason For Recall Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.

Event Detail

Event Id 61776
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 2012-05-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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