January 15, 2015 — The FDA is warning that at least 40 people have been injected and one has died after mistakenly receiving intravenous (IV) saline that was intended for training purposes only.
San Diego-based Wallcur, Inc., recalled the product, Practi-0.9% Sodium Chloride, on January 7 after learning that the product was being misused.
According to the FDA, many serious adverse events have been reported:
“Patients who received simulated IV saline almost immediately upon injection experienced fever, chills, tremors, muscle aches, headaches, and some required hospitalization.”
The FDA does not know if the death was caused by the product.
Adverse events have been reported in seven states: Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.
The problem is that there is a shortage of medical-grade 0.9% saline solution and the training products lack prominent warnings that they are not to be used in humans and animals. Wallcur is planning on fixing the problem by adding clearer labels. In the meantime, the FDA is allowing imports of saline solution from drug-makers in Europe.
The FDA is asking healthcare professionals to visually inspect all IV saline solution bags. Products that are labeled “Wallcur,” “Practi-products,” “For clinical simulation,” or “Not for use in human or animal patients” should be quarantined from products intended for clinical use. Contact Wallcur for directions on how to return the products.