The US Food and Drug Administration (FDA) is warning that Wallcur's simulated IV saline solution, Practi-0.9% sodium chloride solution, has been inappropriately sent to medical clinics, surgical centers, and urgent care facilities in several states.
The solution is meant for training purposes only and should not be used in patients, the agency emphasizes in the new drug safety communication.
The FDA, together with the Centers for Disease Control and Prevention, have identified more than 40 patients who have been injected with the solutions, which are not sterile and not meant for either patient or animal use.
Adverse events associated with the injections have been reported in seven states: Colorado, Florida, Georgia, Idaho, Louisiana, New York, and North Carolina. Reported events include fever, chills, tremors, and headache. Some patients have required hospitalization and one patient has died. The agency says testing is on-going to determine if the death was directly related to the product.
The agency first warned of the use of the simulated IV solutions in patients on December 30, 2014. The company issued a voluntary recall of the related products on January 7. However, the agency notes that most medical facilities have said they were unaware that the IV products they received were simulation products; only one clinic recognized the problem and returned the solutions.
The agency now recommends that clinicians and office staff inspect all IV saline solution bags currently in stock. Any bags labeled with any of these phrases — "Wallcur," "Practi-products," "For clinical simulation," or "Not for use in human or animal patients" — should be returned to the distributor.
