Drug product
Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60 count capsules (UPC 00859667007156), c) 150 count capsules (UPC 00859667007163) , Sunstone Organics Springfield, Oregon 97473, 541-972-3327.
D-0989-2019
Product summary
- Event
- Event 82247
- Status
- Terminated
- Classification
- Class I
- Quantity
- N/A
- Official record key
drug-enforcement:D-0989-2019
Official wording
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Code information: Lot #124A
Distribution pattern: California, Nebraska, Oregon, Washington
Derived failure modes
-
Microbial contamination
MICROBIAL CONTAMINATION