Kratom-containing Powder Products by PDX Aromatics: Recall - Potential for Contamination with Salmonella

AUDIENCE: Consumer

ISSUE: PDX Aromatics of Portland, Oregon DBA Kraken Kratom, Phytoextractum, and Soul Speciosa, 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.

See the press release for affected products, lot codes, and photos.

BACKGROUND: PDX Aromatics identified a supplier in their supply chain as the source of Salmonella. The company has removed that supplier and all associated products from its facility.

RECOMMENDATION: Consumers who may be in possession of potentially contaminated products are advised not to consume products labeled with the affected product descriptions and lot codes. All products associated with this recall should be returned to PDX Aromatics.

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

Read the MedWatch Safety Alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm600613.htm