COMPANY ANNOUNCEMENT
King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read Announcement View Product PhotosSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
Generic Drugs - Reason for Announcement:
-
Recall Reason Descriptionmicrobial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.
- Company Name:
- King Bio Inc.
- Brand Name:
-
Brand Name(s)Dr. King’s, Dr. King’s Aquaflora
- Product Description:
-
Product DescriptionHomeopathic liquids: Candida liquid, lymph detox liquid, baby teething liquid
Company Announcement
King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.
Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. King Bio has not received reports of injury or illness.
The Aquaflora HP9 product is used as a Candida control product. The Lymph Detox product is used for symptoms associated with lymphatic toxicity. The Baby Teething product is used for symptoms of teething pain, irritated gums, delayed teething, etc.
Product; | UPC | Lot Numbers | Expiration Date | Distribution |
---|---|---|---|---|
Aquaflora Candida HP9 8 oz. liquid in a carton |
3-57955-80018-7 | 120217R 102017C 101017G 111417C |
12/02/19 10/20/19 10/10/19 11/14/19 |
8,000 bottles nationwide to retail stores and websites |
King Bio Lymph Detox 2 oz. liquid in a carton |
3-57955-50632-4 | 010118BE | 01/01/20 | 276 bottles nationwide to retail stores and websites |
King Bio Baby Teething 2 oz liquid in a carton |
020118F | 13 bottles marked NOT FOR RESALE |
King Bio is notifying its distributors and customers by letter and is arranging for return and/or replacement. of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using/and contact King Bio prior to returning the product.
Consumers with questions regarding this recall can contact King Bio by 866-298-2740 or e-mail custcare1@kingbio.com, Monday – Friday 830am – 430pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Company Contact Information
- Consumers:
- King Bio
- 866-298-2740
- custcare1@kingbio.com
- Media:
- Gene Grabowski
- 202-270-6560
- gene.grabowski@kbglobal.com