August 2012 FDA Recall Drug by Axcentria Pharmaceuticals Llc
D-134-2013 - Stability data does not support expiration date

This Class III drug recall was voluntarily initiated by Axcentria Pharmaceuticals Llc on August 17, 2012 for the product Drug. The FDA reported the reason for recall as stability data does not support expiration date. The product was distributed in MI and the recall is currently terminated.

Recall Number: D-134-2013

Reason for Recall
Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.
Initiated
08-17-2012
Reported
01-30-2013
Quantity
17,679 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62983
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.
Axcentria Pharmaceuticals LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2014
Product Description About Product Description
Full technical description of the product.
Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03

Batch or Lot Expiration Information

Lot# s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014.