FDA-Drug2015-12-09Class II
Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15
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
1,032 tubes
Manufactured in
144 Kingsbridge Road East, Mount Vernon, NY, United States
Products
Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0391-2016Don't want to check this manually?
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