U.S. Food and Drug Administration

 FDA News Release,  May 18, 2001

Licata Enterprises Recalls Digestive Aid Products
Because of Possible Health Risk

For Immediate Release

HUNTINGTON BEACH, CA - May 18, 2001 -- Licata Enterprises of Huntington Beach, California is recalling specific lots of its Acti-Gest and Super Enzyme digestive aid products because after being advised that random tests of one of the ingredients in the product (Pepsin 1:3000 manufactured by American Laboratories, Inc. of Omaha, Nebraska) 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 individuals may suffer only short-term symptoms such as high fever, severe headache, vomiting, nausea, abdominal pain, and diarrhea. Long term complications can include severe arthritis.

The above products were distributed in Southern California, Ohio, and Michigan through health food stores.

The Acti-Gest product is sold under the brand names of Nature's Concept, VP Discount, Clark's Nutrition, Full of Life, Nature's Way Natural Products, and Edson Farms. The Super Enzyme product is sold under the brand name of HSU & Co. Acti-Gest is packaged in an amber plastic bottle with the name "Acti-Gest" prominent on the center panel. The lot number is on the bottom of the bottle as follows: "5800204". No illnesses have been reported to date. Super Enzyme is packaged in a white bottle in both tablets and capsules with HSU & Co. and Super Enzymes prominent on the center panel. The lot number is on the bottom of the bottle as follows: "0050203" and "0090203". No illnesses have been reported to date.

The recall was the result of a routine sampling of the Pepsin 1:3000 raw material by the raw material supplier, American Laboratories, Inc., and may have been found in some samples of the finished product. American Laboratories, Inc. has ceased the production and distribution of the Pepsin 1:3000 and Licata Enterprises as the manufacturer has ceased distribution of the lots and has already recalled from its customers all products on store shelves as the FDA and the company continue their investigation as to what caused the problem.

Anyone who has purchased Acti-Gest or Super Enzymes under the brands listed above with lot numbers "5800204", "0050203", "0090203" should return the product immediately to the place of purchase for a full refund. Consumers with questions should contact Paul Licata, Licata Enterprises at 714-893-0017.

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.