Taro Pharmaceuticals U.S.A., Inc. recalls Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel
Recalled December 12, 2012 · FDA recall D-086-2013 · Taro Pharmaceuticals U.S.A
Hazard
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples. · FDA Class II
Units
39,982 Tubes
Sold at
Nationwide and Puerto Rico
Description
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
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.
Manufacturer(s)
Taro Pharmaceuticals U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →