January 15, 2015 — At least 40 patients were mistakenly given a non-sterile intravenous (IV) solution that was only intended for training purposes, according to a warning from the FDA.
Wallcur Practi-0.9% Sodium Chloride was recalled on January 7. Many patients have been seriously sickened and one has died after receiving the solution.
The FDA warns:
“Patients who received simulated IV saline almost immediately upon injection experienced fever, chills, tremors, muscle aches, headaches, and some required hospitalization.”
One death is associated with the use of these products, but it is unknown if the death was directly related to the product. Adverse events have been reported in Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.
Wallcur intends to fix the problem by adding more prominent warnings that it is not intended for use in humans or animals.
In the meantime, the FDA recommends that all IV saline solution bags should be visually inspected. Make sure that none are labeled “Wallcur,” “Practi-products,” “For clinical simulation,” or “Not for use in human or animal patients.”
The Centers for Disease Control (CDC) and the FDA are collecting samples of Wallcur’s Practi-0.9% solution and testing the product to learn if they may have caused severe adverse events in patients.
The FDA is aware that there is currently a shortage of Sodium Chloride 0.9% Injection (IV normal saline). They are working with manufacturers to increase supply by temporarily allowing imports from Europe. The drug is widely used to treat patients with dehydration and other medical conditions.