March 17, 2014
SNI National Recalls Kratom XL 4 Pack, Maeng Da Kratom 10 Pack, Max Kratom 20 Pack, and Bali Kratom 40 pack Due to Undeclared Drug Ingredients
The Missouri Department of Health and Senior Services received information regarding a recall of all Kratom products,including Kratom XL 4 Pack, Maeng Da Kratom 10 Pack, Max Kratom 20 Pack and Bali Kratom 40 Pack, from distributors and retail locations. These products contain Kratom (Mitragyna Speciosa). Kratom is a botanical that qualifies as a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act.
When marketed as a dietary ingredient, FDA considers kratom to be a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Furthermore, scientific literature discloses serious concerns regarding the toxicity of Kratom in multiple organ systems. Consumption of Kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting and severe withdrawal signs and symptoms.
The products are packaged in clamshell, zip sealed packets and green pill bottles, 4, 10, 20 and 40 count. The products can be identified by their bright green packaging and label which states that it contains Kratom. The products were sold to wholesale distributors in the following states: Alabama, California, Illinois, Missouri, Kentucky, Florida, Oklahoma, Idaho, Colorado, Wisconsin, Massachusetts and Ohio. The products were further distributed by those entities.
The full recall can be found at www.fda.gov/Safety/Recalls/ucm389350.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.