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Manufacturer’s recall of nasal spray contaminated with Burkholderia cepacia complex

Filetype[PDF-775.36 KB]


  • English
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    Details:

    • Corporate Authors:
      Centers for Disease Control and Prevention (U.S.)
    • Description:
      Friday, March 26, 2004, 17:55 EDT (5:55 PM EDT)

      CDCHAN-00193-2004-03-26-UPD-N

      Clinicians should be aware that the Centers for Disease Control and Prevention (CDC) has been notified that additional lots of over-the-counter oxymetazoline HCL 0.05% nasal spray has been recalled because of intrinsic contamination with B. cepacia complex. Some of the recalled lots have been found to be contaminated and could cause serious or potentially life-threatening infections in patients with compromised immune systems, particularly individuals with cystic fibrosis. The product being recalled is an over-the-counter drug product labeled "Major Soothing Twice-A-Day 12 Hour Nasal Spray Decongestant Regular Oxymetazoline Hydrochloride 0.05%. Distributed by Major Pharmaceuticals, Livonia, MI". The lot number can be found on the bottom of the carton and on the back of the bottle label. The lot numbers being recalled are E4410, F4433, H4464, K4496, L4529, L4535, M4536, A4558, A4588, and B4597. 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.

    • Subjects:
    • Series:
      HAN ; 193
    • Document Type:
      HAN Health Update
    • Place as Subject:
      Missouri
    • Location:
      North America
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