Human Sterile Drug Products by KRS Global Biotechnology

A MedWatch Safety Alert was recently added to the FDA Recalls webpage. 

TOPIC: Human Sterile Drug Products by KRS Global Biotechnology: Recall - Due to Lack of Sterility Assurance

AUDIENCE: Consumer, Patient, Health Professional, Pharmacy 

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.

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:
• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.