Fourth baby added to list of Nara Organics victims

The FDA and the CDC are reporting a fourth baby has been added to the list of infant botulism victims linked to Nara Organics Whole Milk Organic Infant Formula.

The latest victim is a resident of California.

All four of the outbreak victims are male babies ranging in age from 2 to 5 months at onset of illness.

All four babies were hospitalized and treated with BabyBIG.

The California Department of Public Health has detected Clostridium botulinum in an opened can of Nara Organics powdered infant formula obtained from the home of one of the infants. FDA has collected unopened samples from the lot numbers fed to the affected infants for testing, but results are not yet available.

The Nara Organics infant formula was manufactured by the German company, Milchwerke “Mittelelbe” GmbH, and packaged by the Danish company, Advanced Nordic Nutrition.

Prior to becoming aware of the outbreak, the FDA conducted inspections at both facilities and documented several deficiencies. As a result of the inspections, the FDA added Milchwerke “Mittelelbe” GmbH to Import Alert 40-05: “Detention Without Physical Examination Of Adulterated And Misbranded Infant Formula.”

Although the infant formula was manufactured in Germany, at least some of the production batches contained whole organic milk powder supplied by Organic West Milk (a California company) and spray-dried by Dairy Farmers of America’s (Fallon, Nevada). This is the same supplier that furnished whole milk powder to ByHeart.

The FDA is continuing to work with all of the firms involved to determine the root cause of the contamination.

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