Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (ND...
FDA Recall #D-0390-2016 — Class II — October 27, 2015
Product Description
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.
Recalling Firm
Geritrex Corp — Mount Vernon, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
9,948 tubes: 3 oz(8,832), 7 oz(1,116)
Distribution
Nationwide
Code Information
Lot #: a)1502156, 1507104 b)1503039, 1507001
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated