Geritrex Corp recalls Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Onl

Recalled December 9, 2015 · FDA recall D-0390-2016 · Geritrex

Hazard

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. · FDA Class II

Units

9,948 tubes: 3 oz(8,832), 7 oz(1,116)

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 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550

Manufacturer(s)

Geritrex Corp

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →