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.
D-155-2013
Product summary
- Event
- Event 63917
- Status
- Terminated
- Classification
- Class I
- Quantity
- 46,752 bottles
- Official record key
drug-enforcement:D-155-2013
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
Code information: Lot # 2J23, Exp 09/15
Distribution pattern: Nationwide.
Derived failure modes
-
Microbial contamination
Microbial Contamination