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Recall Observatory FDA recall evidence

Drug product

Aquaflora High Potency Candida Control Program Homeopathic Formula, Net 16 fl. oz. (1 pt) 473 mL, Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955160366, NDC 57955-1603-6

D-0900-2019

July 20, 2018

Class I

Product summary

Firm
King Bio Inc.
Event
Event 80601
Status
Terminated
Classification
Class I
Quantity
5000 bottles
Official record key
drug-enforcement:D-0900-2019

Official wording

Reason: Microbial contamination

Code information: Lots: 011017A Exp. 01/20; 033116T Exp. 03/19; 052516R Exp. 05/19; 122815A Exp. 12/18

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

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination