News & Press: Patient Safety

KRS Global Biotechnology, Inc. Recalls All Drug Products Due to Lack of Assurance of Sterility

Friday, September 13, 2019  

SIS Patient Safety Alert 09/13/2019: KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility

 This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither SIS nor the FDA endorse either the product or the company.

ISSUE:  KRS Global Biotechnology, is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile to the consumer level. The products are being recalled due to lack of assurance of sterility. Click here for the company announcement, product listing and images.
 
Administration of a drug product intended to be sterile that is not sterile could result in serious infections which may be life-threatening.  To date, KRS Global Biotechnology, has not received any reports of adverse events related to this recall.
 
RECOMMENDATION:  Consumers should contact their physician or healthcare provider if they have any of these recalled products and if they are experiencing any problems that may be related to taking or using these drug products.
 
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

  Source: Food and Drug Administration - Accessed 09/13/2019


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