FDA Recall D-1122-2018

World Organix, LLC · Las Vegas, NV

Class I — life-threatening Terminated 2288 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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

Lot / code: Lot Code: 102710. Best by date: 03/2019

Quantity: 789 50-count pouches, total of 39,450 capsules

Reason for recall

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.

Recall record

Recall number: D-1122-2018
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Nationwide in the USA.
Recall initiated: 2018-06-26
Classified by FDA Center: 2018-08-23
FDA published: 2018-08-15
Terminated: 2024-09-30
Recalling firm: World Organix, LLC
Firm location: Las Vegas, NV

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