FDA-Drug2015-07-22Class III

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

Geritrex Corp
Hazard

CGMP Deviation: Poor container closure of the bulk storage container

Sold states
Nationwide
Affected count
1,488 tubes (1,008 3 oz. tubes and 480 7 oz. tubes)
Manufactured in
144 Kingsbridge Road East, N/A, Mount Vernon, NY, United States
Products
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

Official notice

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

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