MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramSterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility AssuranceAUDIENCE: Pharmacy 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:
Read the MedWatch safety alert, including a link to the press release, at: You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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