MIAMI- The Centers for Disease Control and Prevention (CDC) has been notified of a voluntary recall of over-the-counter oxymetazoline HCl 0.05 percent nasal spray because of intrinsic contamination with Burkholderia cepacia complex. The nasal spray is distributed as "Major Twice-A-Day 12 Hour Nasal Spray." The manufacturer, Propharma Inc., of Miami, has recalled lot No. K4496, released in November 2003, with an expiration date of October 2006.
Preliminary molecular epidemiology indicates that isolates related to the strain found in the nasal spray have been recovered from patients in multiple states. Clinicians should be aware that patients using product from this lot number might have been exposed to B. cepacia complex. Patients with underlying lung disease (especially cystic fibrosis) might be at increased risk for severe infections with B. cepacia complex. Cases of B. cepacia complex infection or colonization associated with use of this product should be reported to the local or state health department and the CDC at (800) 893-0485.