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Recall Observatory FDA recall evidence

Drug product

White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) 60 count capsules (UPC 00859667007354), c) 150 count capsules (UPC 00859667007361), Sunstone Organics Springfield, Oregon 97473 541-972-3327.

D-0988-2019

February 13, 2019

Class I

Product summary

Firm
Todd Holiday dba Sunstone Organics
Event
Event 82247
Status
Terminated
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-0988-2019

Official wording

Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.

Code information: Lot #119

Distribution pattern: California, Nebraska, Oregon, Washington

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    MICROBIAL CONTAMINATION