Safety

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

[Posted 06/22/2018]

AUDIENCE: Consumer, Health Professional

ISSUE: The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines.

The affected products (listed below) can be identified by Lot No.: 0102031800 and Batch No.: 031800. Specifically, the products were distributed to AK, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM NV, NY, OH, OK, OR, PA, PR, SC, SD, TX, VA, WA, WY via the internet.

BACKGROUND: These products have 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.

RECOMMENDATION: Gaia is notifying its customers by e-mail and/or telephone and are urged to return the recalled products to us or immediately discard them.

Consumers with questions regarding this recall can contact the company at fdarecall@gaiaethnobotanical.com or call 24/7 at 702-996-8523.

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

[03/26/2018 - Recall - FDA]
 

Page Last Updated: 06/22/2018
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