ZICAM EXTREME CONGESTION RELIEF NASAL GEL – RECALL OVER BURKHOLDERIA CEPACIA

FDA RECALLS ZICAM EXTREME CONGESTION RELIEF NASAL GEL  OVER CONTAMINATION WITH BURKHOLDERIA CEPACIA

The FDA (U.S. Food & Drug Administration) has issued MedWatch bulletin reporting the recall of ZICAM EXTREME CONGESTION RELIEF NASAL GEL because of the potential for contamination with Burkholderia Cepacia. Consumers are being advised that the manufacturer, Matrixx Initiatives, is recall the non-drip liquid nasal gel because a single lot was found to be contaminated with Burkholderia Cecpacia. The affected Lot is 2J23 with an expiration of 09/15. Reportedly, Burkholderia Cepacia presents little risk to otherwise healthy individuals. However, is poses the potential for “upper airway colonization and secondarily lead to respiratory infections in individuals with a compromised immune system or chronic lung conditions” from delivery through a nasal spray.

The Centers for Disease Control and Prevention (CDC) site provides some general background information on this bacteria in the healthcare setting. The term “Burkholderia Cepacia” refers to a group of bacteria that may be found in soil or water. It may prove resistant to common antibiotics and has been known to cause infections in hospitalized patients. Of most significance is the fact that, this bacteria has a history of being transmitted by contaminated medicines which includes the following:

  • 2005 – CDC was advised by several states of clusters of pneumonia and other infections linked to contaminated mouthwash.
  • 2004 – CDC was advised of a voluntary recall of over the counter nasal spray due to contamination with the complex bacteria.
  • 2004 – CDC was advised of a link between infections in ICU patients and exposure to sublingual probes.

The bacteria can be spread to susceptible persons by the (a) person to person contact; (b) through contaminated surfaces and (c) environmental exposure.

Given the CDC has previously identified a link to nasal sprays and this bacteria, since at least 2004, how, if at all the manufacturers have safeguarded against this potential remains to be seen.

Presently, the manufacturer is notifying distributors and retail customers by way of FEDEX and telephone calls. However, users or consumers are advised to stop using the product and notify Matrixx if they are in possession of a recalled item.

The actual Press Release  is here and depicted above.

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