December 2012 FDA Recall Drug by Matrixx Initiatives Inc
D-155-2013 - Microbial Contamination of Non-Sterile Products

This Class I drug recall was voluntarily initiated by Matrixx Initiatives Inc on December 18, 2012 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-155-2013

Reason for Recall
Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
Initiated
12-18-2012
Reported
02-13-2013
Quantity
46,752 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63917
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Matrixx Initiatives Inc
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0.

Batch or Lot Expiration Information

Lot# 2J23, Exp 09/15