Digestive 3 in 1 Health liquid dietary supplement recalled for potential Salmonella contamination

June 8, 2012
From staff reports
From staff reports

Botanical Laboratories Inc. is recalling 38 bottles of 33.8-oz. "Wellesse Digestive 3 in 1 Health" liquid dietary supplement and 275 bottles of 16-oz. liquid dietary supplement, after a supplier said one of the ingredients could be contaminated with Salmonella, which can be fatal in young children, frail and elderly people, and others with weakened immune systems.

Botanical Laboratories Inc. is recalling 38 bottles of 33.8-oz. "Wellesse Digestive 3 in 1 Health" liquid dietary supplement and 275 bottles of 16-oz. liquid dietary supplement, after a supplier said one of the ingredients could be contaminated with Salmonella, which can be fatal in young children, frail and elderly people, and others with weakened immune systems.

Botanical Laboratories, Ferndale, Wa., and FDA has notified consumers and healthcare professionals.

The supplier, Ingredion Incorporated (formerly Corn Products International) of Westchester, Ill., said its Purimune, galacto oligosaccharide, a soluble fiber shown to be helpful in digestion, had tested positive for Salmonella.

Product lots affected by this recall include: 16-oz. size with "LOT 34441C (followed by a 4-digit time code) A EXP 03/2014" jet coded on the bottom of the bottle. The 33.8-oz. size has "LOT 34552C (followed by a 4-digit time code) A EXP 03/2014" jet coded on the bottom of the bottle.

Both 33.8-oz. and 16-oz “Digestive 3 in 1 Health” were distributed nationwide through retail stores and online retailers. The product was distributed after May 1, 2012.

Drug Topics spoke with Ingredion Incorporated company spokesperson, Claire Regan. “Safety is a high priority for us,” Regan said. “We are working with FDA on the recall. The company has located and isolated more than 99% of the three lots. These are no longer in circulation or use and none of our other ingredients are being recalled.”

Consumers who have purchased “Digestive 3 in 1 Health” with one of the above referenced lot numbers are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at (800) 232-4005.

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 (ie, infected aneurysms), endocarditis, and arthritis.

Consumers are encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online

Download the form or call (800) 332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to (800) FDA-0178.