Medicine recalls
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| The United States: FDA's investigation into patients being injected with simulated IV fluids continues |
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FDA and the Centers for Disease Control and Prevention (CDC) are continuing to investigate multiple instances of Wallcur's simulated intravenous (IV) saline products being administered to patients. These products are not sterile and should not be injected in humans or animals. So far, more than 40 patients have received infusions of the simulated saline products, and there have been many adverse events associated with these incidents including fever, chills, tremors and headache. Some patients were hospitalized, and there is one death associated with the use of these products; it is not known if this death is directly related to the use of the product.
Wallcur initiated a voluntary recall of Practi-0.9% sodium chloride IV solutions. Most medical facilities reported that they were unaware that the IV solution bags were simulation products. At least one clinic recognized the Wallcur product was a simulation product upon receipt, and returned it to the distributor.
Clinicians and office staff are encouraged to take steps to ensure IV solution simulation products are removed from office inventory to eliminate the possible injection of Wallcur simulated products into patients.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm428431.htm
In Hong Kong, there is no registered pharmaceutical products manufactured by Wallcur. Related news has been released by the FDA, and was posted on the Drug Office website on 31 December 2014 and 12 January 2015.
Ends/ Thursday, January 15, 2015
Issued at HKT 15:00
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