Recalls / Class I
Class ID-1012-2018
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, White Horn, 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-1012-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.