FDA Recall D-0521-2019

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

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

Lot / code: 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

Quantity: 105716 bottles

Reason for recall

Microbial contamination

Recall record

Recall number: D-0521-2019
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

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