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Recall Observatory FDA recall evidence

Drug product

Dr. King's Natural Medicine Aquaflora Candida High Potency 9 Multi-Strain Candida Formula, 236 mL, (liquid/liquide), Manufactured by:/Fabrique par: King Bio, Inc. 3 Westside Dr., Asheville, NC 28805 USA Import by: Importe par: Ambiental Solutions Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80036805 UPC 357955180289

D-0962-2019

July 20, 2018

Class I

Product summary

Firm
King Bio Inc.
Event
Event 80601
Status
Terminated
Classification
Class I
Quantity
10418 bottles
Official record key
drug-enforcement:D-0962-2019

Official wording

Reason: Microbial contamination

Code information: Lots: 022218E Exp. 02/20; 011217C Exp. 12/20; 012116A Exp. 01/19; 092816A Exp. 09/19

Distribution pattern: U.S.A. Nationwide, Canada, and Australia.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination