- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- 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
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|
Candida HP9 8
oz. liquid in a
retail stores and
2 oz. liquid in a
retail stores and
|King Bio Baby
Teething 2 oz
liquid in a
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 firstname.lastname@example.org, 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