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

Firm: Taro Pharmaceuticals U.S.A., Inc.

Classification: Class II

Status: Terminated

Report Date: 20121212

Initiation Date: 20121121

Termination Date: 20170411

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

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.