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Nationwide voluntary recall of all products for sterile use from compounding pharmacy located in Cedar Park, Texas
  • Published Date:
    8/14/13
  • Source:
    HAN ; 353
  • Language:
    English
Filetype[PDF - 1.15 MB]


Details:
  • Corporate Authors:
    Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration. ;
  • Series:
    HAN ; 353
  • Document Type:
  • Description:
    August 14, 2013, 16:00:00 ET (4:00:00 PM ET

    CDCHAN-00353

    Summary: The U.S. Food and Drug Administration (FDA) is alerting health care providers and patients of a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, Texas. There have been recent reports of bacterial bloodstream infections potentially related to the company's calcium gluconate infusions.

    CDC and the FDA are working with Texas state officials to determine the scope of the contamination. According to the FDA, information provided by the firm stated that the recalled products (i.e., all products produced and distributed for sterile use by Specialty Compounding) were distributed directly to patients nationwide, with the exception of North Carolina, which received no products. The full text of the recall is available on the FDA website at http://www.fda.gov/Safety/Recalls/ucm364643.htm?source=govdelivery. Also according to the FDA, information provided by the firm stated that recalled products were also distributed to hospitals and physician offices in Texas.

    CDC and the FDA are working with Texas state officials to determine the scope of the contamination.

    According to the FDA, information provided by the firm stated that the recalled products (i.e., all products produced and distributed for sterile use by Specialty Compounding) were distributed directly to patients nationwide, with the exception of North Carolina, which received no products. The full text of the recall is available on the FDA website at http://www.fda.gov/Safety/Recalls/ucm364643.htm?source=govdelivery. Also according to the FDA, information provided by the firm stated that recalled products were also distributed to hospitals and physician offices in Texas.

  • Supporting Files:
    No Additional Files