Recall: Aquaflora Candida HP9, Lymph Detox, Baby Teething Liquids For Microbial Contamination – FDA

by Kim Boateng Posted on July 20th, 2018

Silver Spring, Maryland, USA: The U.S. Food and Drug Administration, FDA, said  today that 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.htmor 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

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Author

Kim Boateng

Kim Boateng

Staff Writer
Phone
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