Zicam Nasal Spray Recalled for Burkholderia cepacia Contamination
Matrixx Initiatives Inc is recalling Zicam Extreme Congestion Relief nasal spray due to potential contamination with Burkholderia cepacia. The recall covers 46,752 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Matrixx Initiatives Inc is recalling Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottles. The recall is due to the potential for microbial contamination with Burkholderia cepacia. The affected product is identified by Lot # 2J23 and an expiration date of 09/15.
The recall involves 46,752 bottles of the product, which were distributed nationwide. The product is developed and distributed by Zicam LLC, a wholly owned subsidiary of Matrixx Initiatives Inc.
Consumers with the affected product should stop using it and contact the manufacturer for instructions on how to return the product or obtain a refund.
The recalled product
- 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.
- Manufacturer
- Matrixx Initiatives Inc
- Category
- Drug — Nasal Spray
- Affected units
- 46,752
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 2J23
- Exp 09/15
Distribution
Distributed nationwide across the United States.
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