Recall: D-086-2013

Class II - Potentially Harmful

Class IIClassification

2012-11-21Initiated

TerminatedStatus

Taro Pharmaceuticals U.S.A., IFirm

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

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

Distribution

Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.