Product: 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
Reason for recall: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Recall initiated: 20151027
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated