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Recall Observatory FDA recall evidence

Food product

Kratom powder labeled in the following ways 1) Enhance Your Life, Kratom Essence Maeng Da Mitragyna speciosa, 150 gras; 2) Bali Kratom, 15 g Powdered; 3) Bali Kratom, 30 g Powdered; 4) Bali Kratom, 60 g Powdered; 5) Bali Kratom, 120 g Powdered; 6) Botany Bay, 1 oz

F-1021-2018

February 09, 2018

Class II

Product summary

Firm
Divinity Product Distribution LLC
Event
Event 79212
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
food-enforcement:F-1021-2018

Official wording

Reason: The firm's dietary supplement products contain kratom (Mitragyna speciosa), 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;

Code information: All lot codes with expiration dates after 1/31/2018

Distribution pattern: Product distributed to the following US states and countries: AK, AL, AR, Austria, AZ, CA, Canada, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, United Kingdom, UT, VA, WA, WI, and WV

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm's dietary supplement products contain kratom (Mitragyna speciosa), 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;