Drug recall: Dr. King's aquaflora Candida High Potency, 8 fl. oz. (236 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA…

U.S.A. Nationwide, Canada, and Australia.

King Bio Inc., Asheville, NC.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

The table shows 60 of 465 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

Drug events that started in 2018

367

Share of these events in Class I

11%

Product records in this event

465

Events of the firm on the register

1

• FDA enforcement report D-0521-2019The FDA record of the first product of this event.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Where was the product distributed?

The FDA record gives this distribution: U.S.A. Nationwide, Canada, and Australia.

What quantity of product is in FDA event 80601?

The event has 465 product records. The first record gives this quantity: 105716 bottles

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many drug recalls of 2018 have the same class?

11% of the 367 drug events that started in 2018 are in Class I.