Recalls / Class I
Class ID-0521-2019
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 aquaflora Candida High Potency, 8 fl. oz. (236 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 35795580018, NDC 57955-8020-89
- Affected lot / code info
- Lot Numbers: 120217R Exp. 12/19; 102017C Exp. 10/19; 101017G Exp. 10/19; 111417C Exp. 11/19; 062818E Exp. 06/20; 122817B Exp. 12/19; 030818B Exp. 03/20; 010716A Exp. 01/19; 011617H Exp. 01/20; 012517M Exp. 01/20; 020717A Exp. 02/20; 021816A Exp. 02/19; 031016C Exp. 03/19; 031016D Exp. 03/19; 033016K Exp. 03/19; 052516J Exp. 05/19; 052918G Exp. 05/20; 062116A Exp. 06/19; 062818A Exp. 06/20; 062818F Exp. 06/20; 090816B Exp. 06/20; 101216A Exp. 10/19; 112315A Exp. 11/18; 112916C Exp. 11/19; 120816N Exp. 12/19
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
- 105716 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-0521-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.