Federal regulators alerted hospitals nationwide Friday night not to use a solution commonly used on heart patients, saying it may be contaminated with the bacteria that caused this year's shortage of flu vaccine.
The Food and Drug Administration issued the alert against use of a PharMEDium Services Magnesium Sulfate with the lot number 100504900049 and an expiration date of April 4, 2005. It is produced by PharMEDium Services of Houston.
The product often is given intravenously to patients undergoing cardiac surgery and was apparently distributed to several hospitals around the country.
So far it has been associated with at least five recent cases of Serratia marcescens infection in a hospital in New Jersey, the FDA said, without identifying the hospital. All patients have responded to treatment with antibiotics and are reportedly recovering well, the agency said.
"This product . . . may be contaminated with Serratia marcescens bacteria that can cause serious, life-threatening illness in patients with compromised immune systems," it said in a statement late Friday night. The FDA, the federal Centers for Disease Control and Prevention and other public health authorities are investigating to determine if other lots of this product may be affected.
Serratia marcescens bacteria is a common contaminant in labs and is the germ officials said tainted the flu vaccine at a British factory. It is blamed for urinary tract infections, infected surgical wounds and pneumonia, usually spread among hospital patients.
Hospitals with questions may contact the company at 847-457-2300. Those wanting to report anything to the FDA regarding the product may contact the agency's MedWatch office at 800-FDA-1088.