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.
Recall initiated: 20121121
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated