FDA Drug Low Class III Terminated

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

Reported: July 22, 2015 Initiated: June 5, 2015 #D-1238-2015

Product Description

Reason for Recall

CGMP Deviation: Poor container closure of the bulk storage container

Details

Recalling Firm: Geritrex Corp
Units Affected: 1,488 tubes (1,008 3 oz. tubes and 480 7 oz. tubes)
Distribution: Nationwide
Location: Mount Vernon, NY

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by Geritrex Corp. Units affected: 1,488 tubes (1,008 3 oz. tubes and 480 7 oz. tubes).

Why was this product recalled? ▼

CGMP Deviation: Poor container closure of the bulk storage container

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on July 22, 2015. Severity: Low. Recall number: D-1238-2015.