FDA recall D-0390-2016

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-10-27

Report date

2015-12-09

Termination date

2018-06-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mount Vernon, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0390-2016