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Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall—due to potential Salmonella contamination

FDA Jun 26, 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 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, and 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 (ie, 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.

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