Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray ...
FDA Recall #D-155-2013 — Class I — December 18, 2012
Product Description
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.
Reason for Recall
Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
Recalling Firm
Matrixx Initiatives Inc — Scottsdale, AZ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
46,752 bottles
Distribution
Nationwide.
Code Information
Lot # 2J23, Exp 09/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated