D-0901-2019 Class I Terminated

Recalled by King Bio Inc. — Asheville, NC

FDA drug recall D-0901-2019 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: 2248 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
2248 bottles

Product Description

Aquaflora Phase II Candida Control Program, Net 16 fl. oz. (1 PT) 473 mL, Homeopathic Formula, Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955160267, NDC 57955-1602-6

Reason for Recall

Microbial contamination

Distribution Pattern

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

Code Information

Lots: 010518G Exp. 07/18; 011617F Exp. 01/20; 021016G Exp. 02/19; 051716P Exp. 02/19; 072315A Exp. 07/18

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0901-2019
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.