Recalls / Class I
Class IF-1382-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.
Product
Nirvanio Bali Kratom all packages, all quantities
- Type
- Food
- Affected lot / code info
- All lots
- Quantity
- Unknown
Why it was recalled
Dietary supplements have the potential to be contaminated with Salmonella.
Recalling firm
- Firm
- Nutrizone LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 9000 Southwest Fwy Ste 410, Houston, Texas 77074-1522
Distribution
- Distribution pattern
- Nationwide (FL, CA,OK,GA,SC,PA,LA,WA,MS,MO,KY,AZ,CO,TX, NY,IL)
Timeline
- Recall initiated
- 2018-03-30
- FDA classified
- 2018-05-07
- Posted by FDA
- 2018-04-25
- Terminated
- 2018-10-11
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-1382-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings.