The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0902-2019·Announced 2019-03-20

King Bio Aquaflora Phase I Candida Control Program Recalled for Microbial Contamination

King Bio Inc. is recalling Aquaflora Phase I Candida Control Program bottles due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which corresponds to a reasonable probability that use of the product will cause serious adverse health consequences or death.

Plain-English summary

King Bio Inc. is recalling specific lots of Aquaflora Phase I Candida Control Program, a homeopathic formula. The recall is being conducted because the product is subject to microbial contamination.

The affected product is a 16 fl. oz. (473 mL) bottle manufactured by King Bio Inc. in Asheville, North Carolina. The recall covers 6,153 bottles with specific lot numbers and expiration dates ranging from 2018 to 2020. The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
Aquaflora Phase I Candida Control Program, Net 16 fl. oz. (1 PT) 473 mL, Homeopathic Formula, Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955160168, NDC 57955-1601-6
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
6,153

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lots: 022218D Exp. 02/20
  • 100917D Exp. 10/19
  • 021717A Exp. 02/20
  • 041816B Exp. 04/19
  • 062816F Exp. 06/19
  • 122815B Exp. 12/18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 465 recalled by King Bio Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 465 products in this recall →

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