Recalls / Class I
Class ID-1122-2018
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
Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3
- Affected lot / code info
- Lot Code: 102710. Best by date: 03/2019
Why it was recalled
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Recalling firm
- Firm
- World Organix, LLC
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 6149 S. Rainbow Blvd #5, N/A, Las Vegas, Nevada 89118
Distribution
- Quantity
- 789 50-count pouches, total of 39,450 capsules
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2018-06-26
- FDA classified
- 2018-08-23
- Posted by FDA
- 2018-08-15
- Terminated
- 2024-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1122-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.