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Recall Observatory FDA recall evidence

Drug product

Gaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

D-1016-2018

June 20, 2018

Class I

Product summary

Firm
Gaia Ethnobotanical LLC
Event
Event 80343
Status
Terminated
Classification
Class I
Quantity
unknown
Official record key
drug-enforcement:D-1016-2018

Official wording

Reason: Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Code information: Lot # 0102031800

Distribution pattern: Nationwide.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Contamination of Non-Sterile Product; FDA analysis found salmonella