Recalls / Class II
Class IID-086-2013
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.
- Brand name
- Fluorouracil
- Generic name
- Fluorouracil
- Active ingredient
- Fluorouracil
- Route
- Topical
- NDC
- 51672-4118
- FDA application
- ANDA090368
- Affected lot / code info
- Lot #s: 118903, Exp. March 2013; 119477, 119483, 119743, Exp. May 2013; 119748, June 2013; 110440, Exp. September 2013; 110599, 110602, 110606, 110607, 110949, 110951, 110953, 110954, 110956, 110958, Exp. October 2013; 110962, 110963, 110965, 111659, 111844, Exp. November 2013; 111845, 111846, Exp. December 2013; 112227, 112228, Exp. January 2014.
Why it was recalled
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, N/A, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 39,982 Tubes
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-11-21
- FDA classified
- 2012-12-04
- Posted by FDA
- 2012-12-12
- Terminated
- 2017-04-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-086-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.