King Bio Recalls Aquaflora Candida Control Formula Due to Microbial Contamination
King Bio Inc. is recalling Aquaflora High Potency Candida Control Program Homeopathic Formula 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 may cause serious adverse health consequences or death, meeting the criteria for a Critical severity score.
Plain-English summary
King Bio Inc. is recalling Aquaflora High Potency Candida Control Program Homeopathic Formula, Net 16 fl. oz. (1 pt) 473 mL, due to microbial contamination. The recall involves 5,000 bottles of the product, which is manufactured by King Bio, Inc. in Asheville, NC.
The affected product is identified by UPC 357955160366 and NDC 57955-1603-6. Specific lots subject to the recall include 011017A (Exp. 01/20), 033116T (Exp. 03/19), 052516R (Exp. 05/19), and 122815A (Exp. 12/18). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.
Consumers who have purchased this product should stop using it and contact King Bio Inc. for further instructions or a refund. The U.S. Food and Drug Administration has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- 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
- Manufacturer
- King Bio Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 5,000
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 (4)
- Lots: 011017A Exp. 01/20
- 033116T Exp. 03/19
- 052516R Exp. 05/19
- 122815A 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.
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