Eclipse Kratom by Tamarack: Recall - Possible Salmonella Contamination

AUDIENCE: Consumer, Patient

ISSUE: Tamarack is voluntarily recalling Eclipse 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 affected powder products are packaged in plastic heat sealed pouches or plastic sealed bottles sold in one gram capsules and powder. Distribution of an estimated 120 units were sold directly to five retailers in Utah.

The recall was initiated after Tamarack Inc. was notified of positive Salmonella test results by the Food and Drug Administration. Tamarack has identified the supplier and source of contaminated product and has ceased the production and distribution of the product.

RECOMMENDATION: Consumers who may be in possession of potentially contaminated products are advised not to consume products labeled Eclipse. All products associated with this recall should be returned to Tamarack Inc. for a full refund. Customers can return product to the place of purchase for a full refund and retail stores will receive a full refund from Tamarack Inc. within 14 business days.

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/ucm602604.htm