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Notice to Readers: Manufacturer's Recall of Nasal Spray Contaminated
with Burkholderia cepacia Complex
On March 24, this notice was posted as an
MMWR Dispatch on the MMWR website
(http://www.cdc.gov/mmwr).
CDC has been notified of a voluntary recall of over-the-counter oxymetazoline HCl 0.05% 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., Miami, Florida) 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 CDC, telephone 800-893-0485.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of
Health and Human Services.
References to non-CDC sites on the Internet are
provided as a service to MMWR readers and do not constitute or imply
endorsement of these organizations or their programs by CDC or the U.S.
Department of Health and Human Services. CDC is not responsible for the content
of pages found at these sites. URL addresses listed in MMWR were current as of
the date of publication. |
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Page converted: 3/25/2004
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