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PharMEDium Services Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution

March 21, 2005

Audience: Pharmacists, Operating Room, and Nursing Personnel

[March 21, 2005] FDA and PharMEDium Services of Houston notified healthcare professionals of the withdrawal of one lot of PharMEDium Services Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution, which 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. 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.

[UPDATE April 8, 2005] - PharMEDium Services is recalling all strengths of 50 ml admixtures of Magnesium Sulfate in 5% Dextrose solution because of a potential lack of sterility assurance for these products. In addition, the company is voluntarily ceasing production and distribution of this product until it can determine and correct the source of this problem.

[April 8, 2005 - Press Release - PharMEDium Services]
[March 18, 2005 - Statement - FDA]

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