May 22, 2001Karuna Brand HCl Nutritional
CA (SafetyAlerts) - Karuna
Corporation 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.
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. Health 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 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: