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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Product Detail

Product Description 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.
Recall Number D-086-2013
Classification Class II
Code Info 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.
Product Distributed Qty 39,982 Tubes
Reason For Recall Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.

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
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