FDA Recall D-0900-2019
King Bio Inc. · Asheville, NC
Class I — life-threatening Terminated 1279 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Microbial contamination
Recall record
- Recall number
D-0900-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- U.S.A. Nationwide, Canada, and Australia.
- Recall initiated
- 2018-07-20
- Classified by FDA Center
- 2019-03-08
- FDA published
- 2019-03-20
- Terminated
- 2022-01-19
- Recalling firm
- King Bio Inc.
- Firm location
- Asheville, NC