Home > FDA MedWatch > FDA MedWatch – iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder Dietary Supplements

FDA MedWatch – iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder Dietary Supplements

iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder Dietary Supplements: Recall – Possible Salmonella Contamination

AUDIENCE: Consumer

ISSUE: Sedona Labs today announced that its supplier of Galactooligosaccharide (GOS) has recalled this ingredient due to a possible Salmonella contamination. As a result,Sedona Labs is now voluntarily recalling certain lots of  iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder distributed between 3/16/2011 and 5/3/2012.   See the firm press release for the lots with their corresponding UPC codes that are included in the recall.

BACKGROUND: Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

RECOMMENDATION: Consumers possessing these products should immediately discontinue their use. To date, no illnesses have been reported in connection with the iFlora Kids Multi-Probiotic or iFlora 4-Kids Powder.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including a link to the firm Press Release at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm311077.htm

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