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Recall Observatory FDA recall evidence

Derived label

Unknown

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

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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