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.
Reported: December 12, 2012 Initiated: November 21, 2012 #D-086-2013
Product Description
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.
Details
- Recalling Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Units Affected
- 39,982 Tubes
- Distribution
- Nationwide and Puerto Rico
- Location
- Hawthorne, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 39,982 Tubes.
Why was this product recalled? ▼
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 12, 2012. Severity: Moderate. Recall number: D-086-2013.
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