Recalls / Class I
Class ID-1009-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Gaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
- Affected lot / code info
- Lot # 0102031800
Why it was recalled
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Recalling firm
- Firm
- Gaia Ethnobotanical LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 2752 Botticelli Dr, Henderson, Nevada 89052-3107
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2018-06-20
- FDA classified
- 2018-07-26
- Posted by FDA
- 2018-07-18
- Terminated
- 2022-01-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1009-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.