FDA recall D-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.

Reason for recall

Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2012-11-21

Report date

2012-12-12

Termination date

2017-04-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-086-2013