Status
Terminated
Drug Enforcement D-155-2013
Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
Classification
Class I
Report Date
February 13, 2013
Termination Date
November 14, 2013
Product Information
- 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.
- Product quantity
- 46,752 bottles
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- Matrixx Initiatives Inc
- Address
-
8515 E Anderson Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-155-2013
- Event ID
- 63917
- Recall initiation date
- December 18, 2012
- Center classification date
- February 7, 2013
- Code info
- Lot # 2J23, Exp 09/15
- More code info
- —