FDA Recall D-155-2013
Matrixx Initiatives Inc · Scottsdale, AZ
Class I — life-threatening Terminated 331 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-155-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide.
- Recall initiated
- 2012-12-18
- Classified by FDA Center
- 2013-02-07
- FDA published
- 2013-02-13
- Terminated
- 2013-11-14
- Recalling firm
- Matrixx Initiatives Inc
- Firm location
- Scottsdale, AZ