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U.S. Department of Health and Human Services

Enforcement Report - Week of July 5, 2012

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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
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot #'s 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, Exp 8/2013 Class II Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications. 100,761 cartons D-1397-2012