Safety Alerts & Recalls

What does this mean?

The bacteria Burkholderia cepacia poses little medical risk to healthy individuals. However, Burkholderia cepacia in a nasal spray could cause the bacteria to remain and grow in the upper airway and could lead to respiratory infections in individuals with a weakened immune system or those with chronic lung conditions, such as cystic fibrosis. The bacteria is resistant to many antibiotics and may be difficult to treat in this sensitive population if an infection occurs.

Please check your medicine cabinet and other places where you keept over-the-counter medicines to see if you have the recalled Zicam product. If you have lot 2J23 of Zicam Extreme Congestion Relief nasal gel, you should stop using the product and contact Matrixx for a full refund at 1-877-942-2626 from 8am-8pm Central Time Mondays-Fridays and 9am-1pm Central Time on Saturdays.

Consumers with questions regarding this recall can contact Matrixx at 1-877-942-2626 at the times stated above or via the internet at www.zicam.com.

Contact your healthcare provider if you have used this recalled product and you have concerns about your health.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Zicam Extreme Congestion Relief Nasal Gel Recalled Because of Bacteria Contamination

Matrixx Initiatives has recalled one lot of Zicam Extreme Congestion Relief nasal gel. The bacteria Burkholderia cepacia was found in a single sample of the product taken from the lot 2J23, with the expiration date 09/15. The problem was detected during a routine review at the manufacturing facility. Although tests on additional samples from the same lot have shown no evidence of the bacteria, the manufacturer is recalling lot 2J23 as a precaution.

Zicam Congestion Relief nasal gel 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 a product NDC number 62750-005-10. No other Zicam products were involved in this recall.

For more information, please visit: more information here

Source: Manufacturer
Publication Date: 2012-12-19
Last Updated: 2012-12-19
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