KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility

KRS Global Biotechnology, Inc. 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, Inc. has not received any reports of adverse events related to this recall.

The affected products are listed below and include a lot number and expiration date. The products can be identified by a KRS Global Biotechnology, Inc. label. Products were distributed nationwide to hospitals, doctor's offices, surgical centers, pharmacies, veterinarians and patients.

KRS Global Biotechnology, Inc. is notifying its customers by mail, telephone, or email and is arranging for credit of all recalled products.

Health Care Providers that have these products which are being recalled should stop using them and return to KRS Global Biotechnology, Inc.

Consumers that have these products which are being recalled should stop using them and contact their doctor or health care provider.

Consumers with questions regarding this recall can contact KRS Global Biotechnology, Inc. by phone 888-398-9950 or [email protected]. We are available Monday through Friday from 9 AM to 5 PM EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug 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

To report adverse events in animals, follow the instructions for submitting an electronic Form FDA 1932a at www.fda.gov/reportanimalAE.

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