Summary

Company Announcement Date: June 21, 2018 FDA Publish Date: June 21, 2018 Product Type: Dietary Supplements

Drugs

Nutritional Supplement

Generic Drugs Reason for Announcement: Recall Reason Description Salmonella Company Name: Gaia Ethnobotanical, LLC Brand Name: Brand Name(s) Gaia Ethnobotanical Product Description: Product Description Kratom Products

Company Announcement

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“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.

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.

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.

Label Size Packaging Gaia Ethnobotanical Bali Gold 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Elephant 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Ganesh MD 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Green Dragon 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Green Horn 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Green Kapuas Hulu 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Green Malay 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Green MD 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Green Thai 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Plantation Green MD 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Plantation Red MD 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Plantation White MD 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Purple 8-1 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Red Bali 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Red Borneo 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Red Dragon 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Red Horn 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Red Kapuas Hulu 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Red MD 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Red Thai 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Super Green Malay 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical White Borneo 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical White Horn 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical White MD 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical White Thai 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Yellow Thai 1oz, 250g, 1kg Plastic Bag Gaia Ethnobotanical Yellow Vietnam 1oz, 250g, 1kg Plastic Bag

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.