FDA recall D-1238-2015

Geritrex Corp · Class III · drug

Product

Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount Vernon, NY 10550

Reason for recall

CGMP Deviation: Poor container closure of the bulk storage container

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-06-05
Report date: 2015-07-22
Termination date: 2017-03-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mount Vernon, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1238-2015