Simulated IV saline products under FDA investigation

January 22, 2015

FDA and the Centers for Disease Control and Prevention (CDC) continue 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.

Smeeding

FDA and the Centers for Disease Control and Prevention (CDC) continue 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 product, and 17 patients have become ill and 1 has died after receiving IV fluids that 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 there had been reports of serious adverse events associated with use of some of Wallcur's 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. Most medical facilities reported that they were unaware that the IV solution bags were simulation products. At least 1 clinic recognized the Wallcur product was a simulation product upon receipt, and returned it to the distributor.

Compounding may not be the best solution during a saline shortage

“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 as well as 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 and Hospital Pharmacy consulting organization, and president of TPG, National Payer Roundtable.

Formulary managers must be vigilant when it comes to certification of quality of product, purchasing from known sources, and caution when buying from unknown supplier entities.

Saline shortages: A 3-step action plan

FDA said many patients in Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado have experienced adverse effects, including fever, chills, tremors, and headache.

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FDA is working with distributors and clinics to determine how the products entered the supply chain.