CLASS II Drug recall · Reported 9 Dec 2015 · FDA Enforcement Report

Carbo-O-Philic 40 Gel 40% (Urea) recalled by Geritrex

Geritrex is recalling Carbo-O-Philic 40 Gel 40% (Urea), distributed nationwide in the US. The recall was initiated on 27 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 1502078, 1504139

Quantity recalled1,032 tubes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0391-2016
FDA event ID: 72509
Recalling firm: Geritrex, Mount Vernon, NY
Classification: Class II
Status: Terminated
Recall initiated: 27 Oct 2015
FDA classified: 27 Nov 2015
Reported: 9 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Labeling Errors
Drug class: Creams, Ointments & Gels

Timeline

27 Oct 2015	Recall initiated by company
27 Nov 2015	Classified by FDA	+31 days
9 Dec 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot # 1502078, 1504139

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 72509

This product is part of a recall event; the main page for the event is GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories recalled.

Reported	Class	Recall	Company	Reason	Where
9 Dec 2015	CLASS II	GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories recalled	Geritrex	Labeling Errors	Nationwide
9 Dec 2015	CLASS II	Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) recalled by Geritrex	Geritrex	Labeling Errors	Nationwide
9 Dec 2015	CLASS II	Polyethylene Glycol 3350-GRX Powder 100% jars a) recalled by Geritrex	Geritrex	Labeling Errors	Nationwide

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