Safety

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

[Posted 04/19/2018]

AUDIENCE: Consumer

ISSUE: Viable Solutions of Nampa, ID has initiated a recall of certain Kratom-containing powder products, because it 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), endocarditis and arthritis.

BACKGROUND: The potentially affected powder products are packaged in kaft paper, foil-lined heat sealed pouches and sold in 25 grams, 100 grams, 250 grams, and 1000 grams sizes. The units were sold directly to consumers nationwide in January and February of 2018 via company websites.

RECOMMENDATION: Consumers who may be in possession of potentially contaminated products are advised not to consume products from those LOT numbers. All products associated with this recall should be returned to Viable Solutions for a full refund. Customers can return product to company for a full refund within fourteen (14) days by contacting Viable Solutions LLC.

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

  • Complete and submit the report Online: www.fda.gov/MedWatch/report

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/17/2018 - Recall Notice - FDA]

Page Last Updated: 04/19/2018
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