FDA-Drug2015-12-09Class II
Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550
Geritrex Corp
Hazard
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Sold states
Nationwide
Affected count
9,948 tubes: 3 oz(8,832), 7 oz(1,116)
Manufactured in
144 Kingsbridge Road East, Mount Vernon, NY, United States
Products
Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0390-2016Don't want to check this manually?
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