Dr. King's aquaflora Candida High Potency, 8 fl. oz. (236 mL), King Bio, Inc., 3 Westside Dr. As...

FDA Drug Recall #D-0521-2019 — Class I — July 20, 2018

Recall Summary

Recall Number D-0521-2019
Classification Class I — Serious risk
Date Initiated July 20, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm King Bio Inc.
Location Asheville, NC
Product Type Drugs
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.

Lot / 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

Other Recalls from King Bio Inc.

Recall # Classification Product Date
D-0739-2019 Class I Dr. King's SafeCare Rx LymePlex, 2 fl. oz. (59 ... Jul 20, 2018
D-0863-2019 Class I Dr. King's SafeCare Rx CS-Lymph Hodgkins, 2 fl.... Jul 20, 2018
D-0885-2019 Class I Dr. King's SafeCare Rx Smoke Control, 2 fl. oz.... Jul 20, 2018
D-0786-2019 Class I Dr. King's SafeCare Rx Gout Symptom Relief, 2 f... Jul 20, 2018
D-0651-2019 Class I Dr. King's Natural Medicine Homeopathic Climate... Jul 20, 2018

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.