Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance

AUDIENCE: Health Professional, Risk Manager

ISSUE: Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.

BACKGROUND: The affected products include all lots distributed February 16, 2017, to July 19, 2017, remaining within expiry, and they would be packaged in a syringe or IV bag.

RECOMMENDATION: Cantrell Drug Company is notifying its customers by email and phone, and is arranging for the return of all recalled products. Anyone with 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, including a link to the firm's press release, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm568561.htm