Carb-O-Philic 40 Cream recalled over manufacturing violations

Recall date

June 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Geritrex Corp recalls 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 b…

Recall number

D-1238-2015

FDA classification

Class III

Brand / firm

Geritrex Corp

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviation: Poor container closure of the bulk storage container

Class III means the product violates regulations but is not likely to cause harm.

What 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