Enforcement Report - Week of December 12, 2012
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Event Detail
| Event ID | 63685 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Taro Pharmaceuticals U.S.A., Inc. |
| City | Hawthorne |
| State | NY |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-21 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide and Puerto Rico |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6. | Lot #s: 118903, Exp. 03/2013; 119477, 119483,119743, 119748, Exp. 05/2013, 110440, Exp. 07/2013; 110951, Exp 08/2013; 110599, Exp. 09/2013; 110602, 110606, 110607, 110949, 110953, 110954, 110956, 110958, 110963, Exp. 10/2013; 110962, 110965, 111659, 111844, 111845, 111846, Exp. 11/2013; 112227, 112228, Exp. 12/2013. | Class II | Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples. | 39,982 Tubes | D-086-2013 |
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