News Briefs: FDA issues nationwide alert on one lot of intravenous solution
FDA issues nationwide alert on one lot of intravenous solution
The FDA has issued a nationwide alert against the use of PharMEDium Services Magnesium Sulfate 1 g in 50 mL D5W (piggyback) IV solution, lot number 100504900049, and expiration date 4/4/05. This product is manufactured by PharMEDium Services of Houston and may be contaminated with Serratia marcescens bacteria that can cause serious, life-threatening illness in patients with compromised immune systems.
This product frequently is administered intravenously to patients undergoing cardiac surgery and apparently was distributed to several hospitals around the country. To date, it has been associated with at least five 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 the FDA that it is in the process of withdrawing this lot from hospitals. FDA, the CDC, 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.
The FDA has issued a nationwide alert against the use of PharMEDium Services Magnesium Sulfate 1 g in 50 mL D5W (piggyback) IV solution, lot number 100504900049, and expiration date 4/4/05. This product is manufactured by PharMEDium Services of Houston and may be contaminated with Serratia marcescens bacteria that can cause serious, life-threatening illness in patients with compromised immune systems.Subscribe Now for Access
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