U.S. Food and Drug Administration

 FDA News Release,  May 22, 2001

Natural Organics, Inc. Cooperates in the Recall of Digestive Aid Dietary Supplements Because of Possible Salmonella Contaminated Raw Material Supplied by American Laboratories, Inc.

For Immediate Release

MELVILLE, NY- May 22, 2001 -- Natural Organics, Inc. of Melville, New York, is recalling approximately 9800 bottles of its Nature's Plus brand digestive aid dietary supplements that contain the raw material pepsin supplied by American Laboratories, Inc. of Omaha, Nebraska. Although Natural Organics' tests of raw material and finished products were negative for Salmonella, random samples of American Laboratories, Inc. raw material have tested positive for Salmonella.

The presence of Salmonella, if contained in the product, 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 serious illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Bottles of Nature's Plus digestive aid dietary supplements were distributed from February 12, 2001, to May 1, 2001, to retail stores nationwide.

Products are packaged in brown bottles with yellow and green labels. Lot numbers are printed on the bottom of each container. The products being recalled are as follows:

• DIGESTIVE ENZYME - Product Number 4450
  Lot Number: 1008884
• NATURE CLEANSE BOTANICLEANSE TABS - Product Number 1138
  Lot Number: 1008597
• BETAINE HCL - Product Number 4370
  Lot Number: 1006874
• ULTRA-ZYME - Product Numbers 4452, 4453
  Lot Numbers: 1007116, 1007110, 1005942, 1005943, 1009596, 1009520, 1007562, 1006906

No illnesses from these products have been reported to date.

No other lots of product manufactured by Natural Organics are involved or affected by this recall.

The recall is the result of a routine sampling program by American Laboratories, Inc. of Omaha, Nebraska, which detected salmonella in its raw material, pepsin, that was used in some of Nature's Plus digestive aid dietary supplements. FDA's investigation of the situation continues.

Consumers who purchased this product are urged not to consume it and should instead destroy it or return it to the place of purchase for a full refund. Consumers with questions may contact the company at 631-293-1170, ext. 474.

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.