Powdered formula contamination
This article was originally published in The Tan Sheet
Executive Summary
Methods to validate that milk-based powdered infant formulas do not contain the pathogen Enterobacter sakazakii posted on 1CFSAN Web site. Directions, required equipment and materials, media and reagents are referenced in guidelines. In late March, Mead Johnson announced recall of Portagen powdered formula due to possible contamination (2"The Tan Sheet" April 15, 2002, In Brief)...
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CDC report on Portagen
"Clinicians should be aware that powdered [infant] formulas are not sterile products and might contain opportunistic bacterial pathogens," CDC says in April 12 Morbidity & Mortality Weekly Report summarizing premature infant's April 2001 death from meningitis caused by Enterobacter sakazakii. Infant became ill after being tube-fed Portagen, Mead Johnson's nutritional powder for infants who cannot digest or absorb fats. BMS division announced recall of Portagen batch at issue March 29; product is intended for use under doctor's supervision and is not typically sold at retail. In a letter to healthcare professionals April 12, FDA says "several outbreaks" of the infection in neonatal intensive care units worldwide have been associated with milk-based powdered infant formulas. Agency recommends powdered formulas "not be used in neonatal intensive care settings unless there is no alternative available"...