Reported Dec 12, 2012 · Terminated
Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel…
Taro Pharmaceuticals U.S.A., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Taro Pharmaceuticals U.S.A., Inc. · 3 Skyline Dr · Hawthorne, NY · 10532-2174
Is this the product you have?
- Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd
- byTaro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist
- byTaro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6
- Lot codes and dates
Lot #s: 118903Exp. March 2013119477119483119743Exp. May 2013119748June 2013110440Exp. September 2013110599110602110606110607110949110951110953110954110956110958Exp. October 2013110962110963110965111659111844Exp. November 2013111845111846Exp. December 2013112227112228Exp. January 2014
- Amount recalled
- 39,982 Tubes
Where it was sold
- Nationwide
- PR
Why it was recalled
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
This product could cause temporary or reversible health problems — stop using it.
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