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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