Recalls / Class I
Class ID-0962-2019
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
Dr. King's Natural Medicine Aquaflora Candida High Potency 9 Multi-Strain Candida Formula, 236 mL, (liquid/liquide), Manufactured by:/Fabrique par: King Bio, Inc. 3 Westside Dr., Asheville, NC 28805 USA Import by: Importe par: Ambiental Solutions Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80036805 UPC 357955180289
- Affected lot / code info
- Lots: 022218E Exp. 02/20; 011217C Exp. 12/20; 012116A Exp. 01/19; 092816A Exp. 09/19
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
- 10418 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-0962-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.