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Zicam Extreme Congestion Relief Nasal Gel: Recall - Contamination With Burkholderia Cepacia
AUDIENCE: Consumer
ISSUE: Matrixx Initiatives notified the public of a recall of one lot of Zicam Extreme Congestion Relief nasal gel. Burkholderia cepacia was found in a single sample of the product taken from the affected lot. The problem was detected during a routine review at the manufacturing facility. Tests on additional samples from the same lot have shown no evidence of the organism.
Burkholderia cepacia poses little medical risk to healthy individuals. However, Burkholderia cepacia in a nasal spray could cause upper airway colonization and secondarily lead to respiratory infections in individuals with a compromised immune system or those with chronic lung conditions, such as cystic fibrosis. The organism is resistant to many antibiotics and may be difficult to eradicate in this sensitive population if an infection occurs.
The affected lot is 2J23, Expiration 09/15.
BACKGROUND: The product is a non-drip liquid nasal gel used as a nasal decongestant and is packaged in a 0.5 oz. spray bottle contained in an outer carton, bearing NDC number 62750-005-10. The product was distributed to retailers nationwide throughout the United States.
RECOMMENDATION: Matrixx is notifying its distributors and retail customers by FEDEX letter and by phone and is arranging for return of all recalled products. Consumers that have the affected lot of Zicam Extreme Congestion Relief nasal gel should stop using the product and contact Matrixx. See the Press Release for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the press release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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