Status
Terminated
Drug Enforcement D-086-2013
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Classification
Class II
Report Date
December 12, 2012
Termination Date
April 11, 2017
Product Information
- 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.
- Product quantity
- 39,982 Tubes
- Reason for recall
- Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Address
-
3 Skyline Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-086-2013
- Event ID
- 63685
- Recall initiation date
- November 21, 2012
- Center classification date
- December 4, 2012
- 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.
- More code info
- —