Contributed by Carla Sharetto| 21 March, 2005 16:50 GMT
The questionable IV solution 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 US Food and Drug Administation has issued a nationwide alert against the use of an IV solution that may be contaminated with bacteria that can cause life-threatening illness in patients with compromised immune systems.
The product is PharMEDium Services Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution, lot number 100504900049, with expiration date 4/4/05. It is manufactured by PharMEDium Services of Houston, Texas.
Five Patients Infected
This product is frequently 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 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.
Investigation Continues
PharMEDium Services has notified FDA that it is in the process of withdrawing this lot from hospitals. FDA, the US 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 PharMEDium at 1-847-457-2300. Persons wanting to report anything to the Food and Drug Administration regarding this products may contact FDA's MedWatch office at 1 800-FDA-1088. |
Home 
Drug Safety 
