FDA-Drug2012-12-12Class II
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.
Taro Pharmaceuticals U.S.A., Inc.
Hazard
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Sold states
Nationwide and Puerto Rico
Affected count
39,982 Tubes
Manufactured in
3 Skyline Dr, N/A, Hawthorne, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-086-2013Don't want to check this manually?
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