The discovery of fungus particles in an intravenous solution produced by Med Prep Consulting Inc., of Tinton Falls, N.J., has prompted a recall of the product and a temporary halt in production at the facility.
A Connecticut hospital discovered floating fungus particles in five bags of magnesium sulfate intravenous solution, Fox News reported. On March 18, the U.S. Food and Drug Administration (FDA) announced a voluntary nationwide recall of all products from Med Prep Consulting Inc., a specialty pharmacy. In addition to the Connecticut facility that detected the fungus, the magnesium sulfate may have been distributed to other facilities in Connecticut, New Jersey, Pennsylvania, and Delaware, according to the FDA.
Until further notice, health care providers should stop using all products made by Med Prep Consulting Inc. and return them to the company, the FDA said.
“Giving a patient a contaminated injectable drug could result in a life-threatening infection,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “We do not have reports of patient infections. However, due to a lack of sterility assurance at the facility and out of an abundance of caution, this recall is necessary to protect patients.”
In 2012, contaminated steroid injections produced by the New England Compounding Center (NECC) were responsible for a multistate outbreak of fungal meningitis and secondary infections. To date, more than 700 people in 20 states have been sickened by the tainted injections and 50 people have died, according to the U.S. Centers for Disease Control and Prevention (CDC). A number of lawsuits have been filed against NECC, which has since gone out of business.
The FDA asks health care professionals and consumers to report any adverse reactions to the magnesium sulfate solution to the FDA’s MedWatch program: www.fda.gov/medwatch/report.htm