Company Announcement – June 8, 2016
Pharmavite LLC is recalling specific lots of Nature Made® products detailed in the chart below due to possible Salmonella or Staphylococcus aureus contamination.
We are initiating this recall out of an abundance of caution to protect public health. Pharmavite is working closely with the FDA to implement this recall and we are notifying all retail customers and distributors to remove the product from store shelves immediately. No other products are impacted by this recall. The recalled products were distributed nationwide to various major retailers.
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.
The following products are included in the recall:
DescriptionCountLot #UPC CodeNature Made® Adult Gummies Multi9011960660-31604-02841-115011960710-31604-04172-415012050520-31604-04172-4Nature Made® Adult Gummies Multi + Omega-315011736000-31604-04173-1Nature Made® Adult Gummies Multi for Her plus Omega-3s10011960480-31604-04236-315011960500-31604-04275-2Nature Made® Super B Complex w/C & Folic Acid Tablets14011737790-31604-02727-846011709870-31604-02728-546012047350-31604-02728-536011731460-31604-02729-236012040010-31604-02729-2
The lot number can be found on the back panel next to the expiration date. Products that fall within the lots indicated should not be consumed. 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.
The recall was initiated after it was discovered that Salmonella and/orStaphylococcus aureus testing were not completed properly on these specific batch lots. Pharmavite has identified the cause of the error, is taking the matter very seriously and has implemented corrective actions to rectify the issue.
Pharmavite cares deeply about the health and safety of consumers and we apologize for any inconvenience.
Source : FDA Safety Alert
When a FDA announces any alert or approval, the PHAF posts the FDA’s announcement as a public service. PHAF does not endorse either the product or the company.