FDA recall D-0391-2016

Geritrex Corp · Class II · drug

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

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-0391-2016