Drug recall D-086-2013

Class II Terminated reported Dec 12, 2012

Product

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.

Reason for recall

Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.

Lots and codes

Lot #s: 118903, Exp. March 2013; 119477, 119483, 119743, Exp. May 2013; 119748, June 2013; 110440, Exp. September 2013; 110599, 110602, 110606, 110607, 110949, 110951, 110953, 110954, 110956, 110958, Exp. October 2013; 110962, 110963, 110965, 111659, 111844, Exp. November 2013; 111845, 111846, Exp. December 2013; 112227, 112228, Exp. January 2014.

Recall details

Recalling firm
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY
Quantity
39,982 Tubes
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
November 21, 2012
Terminated
April 11, 2017

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