D-0521-2019 Class I Terminated

Recalled by King Bio Inc. — Asheville, NC

FDA drug recall D-0521-2019 was initiated by King Bio Inc. on Jul 20, 2018 and is designated Class I. Reason for recall: Microbial contamination The recall status is terminated (terminated Jan 19, 2022). Affected quantity: 105716 bottles.

Recall Details

Product Type
Drugs
Report Date
Mar 20, 2019
Initiation Date
Jul 20, 2018
Termination Date
Jan 19, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
105716 bottles

Product Description

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

Reason for Recall

Microbial contamination

Distribution Pattern

U.S.A. Nationwide, Canada, and Australia.

Code Information

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

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0521-2019
openFDA file date
Oct 6, 2026
Loaded by RegDataLab
Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.