June 2015 FDA Recall Drug by Geritrex Corp
D-1238-2015 - CGMP Deviation

This Class III drug recall was voluntarily initiated by Geritrex Corp on June 5, 2015 for the product Drug. The FDA reported the reason for recall as cgmp deviation. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1238-2015

Reason for Recall
CGMP Deviation: Poor container closure of the bulk storage container
Initiated
06-05-2015
Reported
07-22-2015
Quantity
1,488 tubes (1,008 3 oz. tubes and 480 7 oz. tubes)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71441
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Geritrex Corp
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-13-2017
Product Description About Product Description
Full technical description of the 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 Vernon, NY 10550

Batch or Lot Expiration Information

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