Company Expands Recall of IV SolutionApr 8, 2005 | AP PharMEDium Services of Houston on Friday expanded its recall of a solution commonly used in hospitals for heart patients after a second outbreak of bacteria that may have contaminated the product.
The recall is for all strengths of "50 ml admixtures of Magnesium Sulfate in 5% Dextrose solution," the company said in a statement distributed by the Food and Drug Administration.
On March 18, the FDA alerted hospitals nationwide that the solution, often given intravenously to patients undergoing cardiac surgery, may be contaminated with Serratia marcescens bacteria. Life-threatening illness in patients with compromised immune systems can result from exposure, the FDA said.
The products subject to the expanded recall are those labeled under the following service codes: 2K2410, 2K2411, 2K2412, 2K2413 and 2K2419. All were manufactured by PharMEDium Services and were distributed to several hospitals around the country, the company said.
The recall in March followed reports of five cases of Serratia marcescens infection in a hospital in New Jersey, the company said. On Friday, FDA spokesman Brad Stone said the second outbreak occurred at a hospital in South Dakota, but he had no details.
Serratia marcescens bacteria, a common contaminant in labs, is the germ officials said tainted the flu vaccine at a British factory and led to a shortage of vaccine in the United States. It has been linked to urinary tract infections, infected surgical wounds and pneumonia.