Carbo-O-Philic 40 Gel 40% recalled over labeling errors

Recall date

October 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 Corpor…

Recall number

D-0391-2016

FDA classification

Class II

Brand / firm

Geritrex Corp

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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