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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Nestlé HealthCare Nutrition Announces Nationwide Voluntary Recall of OPTIFAST® Honey Nut ‘n Oat Nutritional Bars Due to Possible Peanut Corporation of America (PCA) Contamination and Potential Health Risk

 

Contact:
Mary Wade
952-848-6040

 

FOR IMMEDIATE RELEASE -- Minneapolis, MN (February 3, 2009) – Nestlé HealthCare Nutrition, Inc., manufacturer of the OPTIFAST line of weight loss products, today announced a voluntary recall of its OPTIFAST® Honey Nut ‘n Oat Nutritional Bars (Carton UPC Code 0-43900-39017-8) for U.S. distribution with the following LOT CODES AND EXPIRATION DATES: 0397A EXP FEB 08, 1317A EXP MAY 08, 1577A EXP JUN 08, 3247A EXP NOV 08, 538 EXP FEB 09, 1558A EXP JUN 09, 1998A EXP JUL 09, 2198A EXP AUG 09, 2618A EXP SEP 09, because the product contains peanut butter that was manufactured by Peanut Corporation of America (PCA), which is the focus of an ongoing Salmonella investigation by the United States Food & Drug Administration (FDA). PCA is one of the suppliers of peanut ingredients to the company’s contracted manufacturer of the OPTIFAST Honey Nut ‘n Oat Nutritional Bars.

There have been no cases of illness or adverse effects reported to Nestlé HealthCare Nutrition. No other products within the Nestlé HealthCare Nutrition and OPTIFAST product portfolios, including OPTIFAST® Peanut Butter Nutritional Bars, are affected by this recall. No Salmonella contamination has been detected in the OPTIFAST Honey Nut ‘n Oat Nutritional Bars. This voluntary recall is in line with FDA recommendations.

"The health and safety of our patients are our number one concern,” said David Yates, Regional Business Head, Nestlé HealthCare Nutrition, Inc. “We are communicating directly with our OPTIFAST clinics and are urging all patients who have purchased or are in possession of this product to immediately destroy them. Patients seeking a replacement product are being asked to visit their OPTIFAST Clinic and a replacement product will be issued in its place."

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. For more information on Salmonella, please visit the Centers for Disease Control and Prevention's Web site at www.cdc.gov (or call 1-800-232-4636).

The OPTIFAST Honey Nut ‘n Oat Nutritional Bars were distributed to patients through OPTIFAST Medical Clinics. The OPTIFAST Honey Nut ‘n Oat Nutritional Bars are not available in retail stores, and are not sold under any other name. Patients having further questions or concerns may contact our Consumer & Product Support Team at 1-800-333-3785, Option 2, from Monday through Friday, 9:00 a.m. to 6:00 p.m. Eastern Standard Time.

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