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

Recall number

D-0390-2016

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 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