Recall Alert: Sterile Drug Products by Cantrell Drug Company—Lack of Sterility Assurance
Monday, November 21, 2016
SIS Patient Safety Alert 11/21/2016: Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance
This is an important alert from the Spine Intervention Society. We send out Patient Safety Alerts when we receive important information regarding products or services that can impact your patients' safety. When companies announce a recall, market withdrawal, or safety alert, the U.S. Food and Drug Administration (FDA) posts the company's announcement as a public service. Neither SIS, nor the FDA endorse either the product or the company.
ISSUE: Cantrell Drug Company is voluntarily recalling certain unexpired sterile drug products due to lack of sterility assurance. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
See the press release for a listing of affected products and lot numbers.
BACKGROUND: The recalled products were distributed nationwide to health care facilities from May 25 to October 31, 2016.
RECOMMENDATION: Cantrell Drug Company will begin notifying its customers by email and phone and is arranging for the return of all recalled products. Consumers who have product subject to the recall should stop using it and contact the company.
To return medication or request assistance related to this recall, contact Cantrell Drug Company at 877-666-5222, Monday through Friday between 9 a.m. and 5 p.m. CST.
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: www.fda.gov/MedWatch/report
- Download form 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
Read the MedWatch safety alert.
Source: U.S. Food and Drug Administration (FDA) (Accessed: 11/21/2016)