Manufacturer’s Recall of Nasal Spray Contaminated with Burkholderia cepacia complex [Friday, March 26, 2004, 17:55 EDT (5:55 PM EDT)]

Details

• Corporate Authors:
  Centers for Disease Control and Prevention (U.S.). Health Alert Network (HAN)
• 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.
  
  
• Content Notes:
  Notice of Possible Alert Expiration: The CDC Health Alert, Advisory, Update, and Info Service announcements, distributed by the Health Alert Network (HAN), were active on the date they were originally published. Publication dates have been added to Titles for clarity. A CDC Health Alert, Advisory, Update, and Info Service announcement may expire at any time. They may also be updated or superseded according to later developments. None of the CDC Health Alert, Advisory, Update, or Info Service announcements in the Stacks HAN Collection should be assumed to be current or active. Stacks preserves HAN announcements in order to maintain a record of past CDC actions. Stacks in not designed for up-to-the-minute notifications. For the list of current CDC Health Alert, Advisory, Update, or Info Service announcements, patrons should visit the Health Alert Network (HAN) webpage at https://www.cdc.gov/han/php/about/index.html. For up to the minute reports, subscribe to the HAN email alert system hosted by CDC News & Updates at https://tools.cdc.gov/campaignproxyservice/subscriptions.aspx?topic_id=USCDC_486
  
  Categories of Health Alert Network (HAN) messages:
  
  Health Alert: Requires immediate action or attention, highest level of importance.
  
  Health Advisory: May not require immediate action; provides important information for a specific incident or situation.
  
  Health Update: Unlikely to require immediate action; provides updated information regarding an incident or situation.
  
  HAN Info Service: Does not require immediate action; provides general public health information.
  
  
• Subjects:
  Bacterial Typing Techniques Burkholderia Cepacia Complex Burkholderia Infections Cross Infection Cystic Fibrosis Drug Contamination Drug Recalls Nasal Decongestants Nasal Sprays
• Keywords:
  HAN Health Alert Network
• Source:
  HAN ; 193
• Series:
  Health Alert Network
• Subseries:
  CDC Health Update
• Publisher:
  Centers for Disease Control and Prevention (CDC) (U.S.)
• Document Type:
  Text
• Genre:
  Alert
• Place as Subject:
  Missouri
• Rights:
  Public Domain
• Pages in Document:
  2 unnumbered pages
• Issue:
  00193
• Collection(s):
  Health Alert Network (HAN)
• Main Document Checksum:
  urn:sha-512:9e2fd992f16e67ec0400d2331f79b58889205a46fd016e9632773f306fba17c82846355345485e30ec54a019468cb703b7b256e3be335e4041c82d1ffdada036
• Download URL:
  https://stacks.cdc.gov/view/cdc/25104/cdc_25104_DS1.pdf
• File Type:
  [PDF - 775.36 KB ]