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Recall Observatory FDA recall evidence

Derived label

Unknown

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;

reason.no_named_rule

v1.0.0

Assignment summary

Mode key
unknown
Evidence excerpt
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;
Rule explanation
A recall reason is available, but none of the published named rules supports a failure-mode interpretation.
Firm
Divinity Product Distribution LLC

Field note

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