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Recall Observatory FDA recall evidence

Food product

Kratom capsules labeled in the following ways: 1) Divinity Kratom 10 Capsule Dietary Supplement, Divinity Product LLC, Blue Springs, MO 64015; 2) Divinity Bali Kratom, 10PK Capsules; 3) Divinity Bali Kratom, 20PK Capsules; 4) Divinity Bali Kratom, 40PK Capsules;

F-1020-2018

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-1020-2018

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;