Safety

Company Announcement

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.

King Bio Issues Voluntary Nationwide Recall of All Aqueous-Based Products for Human and Animal Use Due to Possible Microbial Contamination

For Immediate Release

August 27, 2018

Contact

Consumers

1-866-298-2740
 recall@kingbio.com

Announcement

King Bio is voluntarily recalling all of its aqueous-based products for human and animal use (see website link below), within expiry, to the consumer level due to possible microbial contamination.

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. To date, King Bio has not received any reports of illness or injury. King Bio is recalling the products listed on the website link below as a precautionary measure.

A complete list of recalled products and lot numbers can be found at this website.

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 discontinue use/distribution and contact King Bio at recall@kingbio.com to make arrangements to return product. These products were distributed nationwide to distributors and retail stores through August 24, 2018.

Consumers with questions regarding this recall can contact King Bio at 866-298-2740 or e-mail recall@kingbio.com, Monday – Thursday 8:30 am – 3:30 p.m., EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

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: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

FDA Announcement

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Page Last Updated: 08/28/2018
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