The Food and Drug Administration is alerting hospitals and patients to a voluntary recall by a New Jersey compounding pharmacy of all its medications after a fungus was found in bags of one drug shipped to a Connecticut hospital.
The FDA said Monday that there were no reports of injury or illness linked to the drug, made by Med Prep Consulting of Tinton Falls, N.J. Med Prep issued the recall after health-care personnel observed “floating particles, later identified to be a fungus,” in five bags of magnesium sulfate solution, an FDA statement said. Magnesium sulfate is widely used to steady the heartbeat after surgery and to prevent a life-threatening condition of pregnancy known as preeclampsia.
The drug may have also been shipped to 12 other facilities in Connecticut, New Jersey, Pennsylvania and Delaware, said company lawyer Angelo Cifaldi.
The company recalled all 83 of its products and agreed to stop operations until at least March 22, a New Jersey Board of Pharmacy spokesman said. Its 50 customers are in 12 states, including Maryland and Virginia, Cifaldi said.
FDA officials said health-care providers should stop using all products made by Med Prep and return them to the company. Records from the company’s inspection in November by state regulators do not show contamination issues, a state spokesman said.