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FDA is seeking to learn how these Wallcur products, which are not sterile and should not be injected in humans or animals, entered the supply chain.
FDA and the Centers for Disease Control and Prevention (CDC) continue to investigate multiple instances of Wallcur’s simulated intravenous (IV) saline products administered to patients. These products are not sterile and should not be injected into human beings or animals.
Seventeen patients have become ill and one has died after receiving these IV fluids, which were meant to be used for training purposes only.
News of the death comes less than a month after FDA told physicians not to use Wallcur's Practi-0.9% sodium chloride IV solutions for simulation and medical training. FDA said at the time that it had received reports of serious adverse events associated with use of some Wallcur products.
Wallcur, based in San Diego, Calif., initiated a voluntary recall of Practi-0.9% sodium chloride IV bags supplied in 50-mL, 250-mL, 500-mL, and 1,000-mL sizes and the Practi-0.9% sodium chloride 100-mL IV solution bag with sterile distilled water.
“USP 797-800 and the DQSA for 503A and 503B, as well as state boards of pharmacy review, are all requiring better training and documentation. Clearly higher adherence to these standards and careful examination of labeling and expiration dating are all components to making IV medications safe for patient use,” said Jim Smeeding, executive director of the National Association of Specialty Pharmacy, president of ProjectRX, a hospital pharmacy consulting organization, and president of TPG National Payer Roundtable.
Formulary managers have been warned to be vigilant when it comes to certification of quality of product, purchasing from known sources, and caution when buying from unknown supplier entities.
According to FDA, many patients in Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado have experienced adverse effects, including fever, chills, tremors, and headache.
FDA is working with distributors and clinics to determine how the products entered the supply chain.