Geritrex Corp recalls Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corpora
Recalled December 9, 2015 · FDA recall D-0391-2016 · Geritrex
Hazard
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. · FDA Class II
Units
1,032 tubes
Sold at
Nationwide
Description
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Product
Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15
Manufacturer(s)
Geritrex Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →