FDAClass IIDecember 9, 2015

Carbo-O-Philic 40 Gel 40% recall

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…

Why was Carbo-O-Philic 40 Gel 40% recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 1502078, 1504139

Product
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…
Recalling firm
Geritrex Corp
Quantity
1,032 tubes
Distribution
Nationwide
Recall date
December 9, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls