Nature Made (Various Products) by Pharmavite LLC: Recall - Possible Health Risk

AUDIENCE: Consumer

ISSUE: Pharmavite LLC is recalling specific lots of Nature Made products due to possible Salmonella or Staphylococcus aureus contamination.

Salmonella, 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.

The presence of Staph aureus toxin in food may lead to food poisoning. The onset of symptoms in staphylococcal food poisoning is usually rapid and in many cases acute, depending on individual susceptibility to the toxin, the amount of contaminated food eaten, the amount of toxin in the food ingested, and the general health of the victim. The most common symptoms are nausea, vomiting, retching, abdominal cramping, and prostration. Some individuals may not always demonstrate all the symptoms associated with the illness. In more severe cases, headache, muscle cramping, and transient changes in blood pressure and pulse rate may occur.

See the Press Release for a listing of affected products.

BACKGROUND: The recalled products were distributed nationwide to various major retailers.

RECOMMENDATION: Pharmavite is notifying all retail customers and distributors to remove the product from store shelves immediately. Consumers are encouraged to return the affected products to their retailer for a full refund. Consumers with questions may contact the company during normal business hours, Monday through Friday, 7:00 am to 5:00 pm PST at 1-800-276-2878.

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
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/ucm505761.htm