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Manufacturer’s recall of nasal spray contaminated with Burkholderia cepacia complex
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03/25/2004
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Series: HAN ; 192
[PDF-787.49 KB]
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Description:March 25, 2004, 11:20 EST (11:20 AM EST)
CDCHAN-00192-04-03-25-UPD-N
Clinicians should be aware that the Centers for Disease Control and Prevention (CDC) has been notified of a voluntary recall of over-the-counter oxymetazoline HCL 0.05% nasal spray because of intrinsic contamination with B. cepacia complex. The nasal spray is available over the counter and is distributed as: “Major Twice-A-Day 12 Hour Nasal Spray”. Patients with underlying lung disease (especially cystic fibrosis) may be at increased risk for severe infections with B. cepacia complex.
The manufacturer, Propharma Inc., has recalled lot# K4496 released 11/03 with an expiration date of 10/06. Preliminary molecular epidemiology indicates that isolates related to the strain found in the nasal spray have been recovered from patients in multiple states.
CDC is assisting the state of Missouri, investigating several cases of B. cepacia that have been identified in one hospital, to examine the impact of the recalled product on patient safety and the potential spread of B. cepacia within the healthcare setting.
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Pages in Document:2 unnumbered pages
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Volume:192
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