FDA Alerts Health Facilities to Contaminated Magnesium Sulfate Solution
The FDA has issued a nationwide alert to healthcare facilities warning against using a certain lot of magnesium sulfate solution, which the agency said may contain harmful bacteria.
The FDA warning was issued for Pharmedium Services' magnesium sulfate 1 g in 50-mL D5W (piggyback) IV solution, with lot number 100504900049 and an expiration date of April 4, 2005.
The agency said the product might be contaminated with Serratia marcescens bacteria, a bacteria the can cause serious, often life-threatening illnesses in patients with compromised immune systems. Patients undergoing cardiac surgery frequently receive the solution intravenously.
The lot identified by the FDA has been associated with at least five recent cases of Serratia marcescens infection in a New Jersey hospital. The infected patients have been treated with antibiotics and are recovering, the FDA said. Pharmedium is in the process of withdrawing the problem lot from hospitals, the agency said.
The FDA and the Centers for Disease Control and Prevention are investigating the problem to determine if other lots of the solution might be contaminated.