Drug 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.
D-086-2013
Product summary
- Event
- Event 63685
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39,982 Tubes
- Official record key
drug-enforcement:D-086-2013
Official wording
Reason: Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Code information: 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.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out-of-specification