One lot of Zicam Extreme Congestion Relief nasal gel, an over-the-counter medicine used to treat nasal congestion and sinus pressure, is being recalled because an organism was found in a single sample during a routine review at the manufacturing plant where the medicine is produced.
The contaminant, known as Burkholderia cepacia, poses no risk to healthy individuals but in a nasal spray could cause upper airway colonization and secondarily lead to respiratory infections in people with a compromised immune system or people with chronic lung conditions such as cystic fibrosis. Burkholderia cepia is also resistant to many antibiotics and may be difficult to eradicate if an infection occurs.
Zicam Extreme Congestion Relief is a non-drip nasal gel used as a nasal decongestant. It is packaged in a 0.5-ounce spray bottle that is contained in an outer carton with the NDC number 62750-005-10. The medicine was distributed to retailers across the United States.
Retailers are being contacted by Matrixx, makers of Zicam, by FEDEX letter and by phone. Consumers who have bought the affected lot of nasal spray should stop using it immediately and contact Matrixx.
Any side effects with this or any other medicine should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.