FDAClass IIIJuly 22, 2015

Carb-O-Philic 40 Cream recall: CGMP Deviations

Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount…

Why was Carb-O-Philic 40 Cream recalled?

CGMP Deviation: Poor container closure of the bulk storage container

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?

a) Lot # 1502076; Exp. 08/16 b) Lot # 1502077,1503030; Exp. 08/16

Product
Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount…
Recalling firm
Geritrex Corp
Quantity
1,488 tubes (1,008 3 oz. tubes and 480 7 oz. tubes)
Distribution
Nationwide
Recall date
July 22, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls