U.S. Food and Drug Administration

 FDA News Release,  May 17, 2001

Karuna Corporation Recalls HCl Nutritional Product Because of Possible Health Risk

For Immediate Release

NOVATO, CA - May 17, 2001 -- Karuna Corporation of Novato, California is recalling its Karuna brand HCl (Betaine HCl, Glutamic HCl and Pepsin), lot # 0104602, supplement product, because one of the ingredients: Pepsin 1:3000, has the potential to be contaminated with 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), endocrinitis and arthritis.

The above product was distributed in California, Arizona, Washington, Oregon, Minnesota, and Wisconsin through health practitioners.

The product is contained in an opaque white bottle with a red silver and grey-green label with black and white printing. It is clearly labeled HCl in white letters on a red background. The lot # is stamped in black ink on the bottom right hand side of the label as follows: "0104602 02/04". No illnesses have been reported to date.

The recall was the result of a routine sampling, by the manufacturer of the Pepsin 1:3000 concentration contained in the product, which revealed that the finished product contained the bacteria. The manufacturer of the Pepsin 1:3000 has ceased the production and distribution of the product and Karuna Corporation has also ceased distribution of the product as the manufacturing company and the FDA continue their investigation.

Anyone who has purchased Karuna brand HCl (Betaine HCl, Glutamic HCl and Pepsin) lot # 0104602 02/04 should return the product immediately to the place of purchase for a full refund. Consumers with questions should contact Bill Gentner, Karuna Corporation: 1-800-826-7225.

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

The text in this article was prepared by the FDA Office of Public Affairs.