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FDA Alert - March 18, 2005

Breaking News

FDA Issues Nationwide Alert on ONE lot of Pharmedium Services magnesium sulfate solution

ROCKVILLE, MD, March 18, 2005 -- The FDA is issuing a nationwide alert against the use of PharMEDium Services Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution, lot number 100504900049 and expiration date 4/4/05. This product is manufactured by PharMEDium Services of Houston, Texas and may be contaminated with Serratia marcescens bacteria that can cause serious, life-threatening illness in patients with compromised immune systems.

This product is frequently administered intravenously to patients undergoing cardiac surgery and was apparently distributed to several hospitals around the country. To date it has been associated with at least 5 recent cases of Serratia marcescens infection in a hospital in New Jersey. All patients have responded to treatment with antibiotics and are reportedly recovering well.

The firm has notified FDA that it is in the process of withdrawing this lot from hospitals. FDA, the U.S. Centers for Disease Control and Prevention, and other public health authorities are investigating this problem to determine if other lots of this product may be affected. More information will be provided as the investigation develops.

Hospitals with questions may contact the company at 1-847-457-2300. Persons wanting to report anything to the Food and Drug Administration regarding this product may contact FDA's MedWatch office at 1 800-FDA-1088.

Source: FDA

Posted: March 2005


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