Recalls / Class I
Class ID-0900-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lots: 011017A Exp. 01/20; 033116T Exp. 03/19; 052516R Exp. 05/19; 122815A Exp. 12/18
Why it was recalled
Microbial contamination
Recalling firm
- Firm
- King Bio Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 3 Westside Dr, N/A, Asheville, North Carolina 28806-2846
Distribution
- Quantity
- 5000 bottles
- Distribution pattern
- U.S.A. Nationwide, Canada, and Australia.
Timeline
- Recall initiated
- 2018-07-20
- FDA classified
- 2019-03-08
- Posted by FDA
- 2019-03-20
- Terminated
- 2022-01-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0900-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.