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Recall Observatory FDA recall evidence

Drug product

Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical Red Borneo, 1oz, 250g, kg Gaia Ethnobotanical Red Dragon, 1oz, 250g, 1kg Gaia Ethnobotanical Red Horn, 1oz, 250g, 1kg Gaia Ethnobotanical Red Kapuas Hulu 1oz, 250g, 1kg Gaia Ethnobotanical Red MD, 1oz, 250g, 1kg Gaia Ethnobotanical Red Thai, 1oz, 250g,. 1kg Gaia Ethnobotanical Super Green Malay 1oz, 250g, 1kg Gaia Ethnobotanical White Borneo 1oz, 250g, 1kg Gaia Ethnobotanical White Horn, 1 oz, 250g, 1kg Gaia Ethnobotanical White MD, 1 oz, 250 g, 1 kg Gaia Ethnobotanical White Thai, 1oz, 250 g, 1 kg Gaia Ethnobotanical Yellow Thai, 1oz, 250 g, 1kg Gaia Ethnobotanical Yellow Vietnam 1oz, 250g, 1kg

D-1005-2018

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-1005-2018

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