US Drug Recall Register
Class II · Moderate risk Terminated Initiated Oct 27, 2015 (11 years ago)

Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

What was recalled

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

Recalling firm
Geritrex Corp
NDC code
54162-640-03
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0390-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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