FDA recall D-155-2013

Matrixx Initiatives Inc · Class I · drug

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.

Reason for recall

Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.

Distribution

Nationwide.

Key facts

Status
Terminated
Initiation date
2012-12-18
Report date
2013-02-13
Termination date
2013-11-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Scottsdale, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-155-2013