Cantrell Drug Company is recalling all lots of its unexpired sterile drug products because the sterility of the products cannot be guaranteed. The products were distributed to health care facilities across the country except to the states of Connecticut, Hawaii, South Carolina and Vermont.
Administration of these drug products intended to be sterile that are not sterile could cause serious infections in patients, some of which can be fatal. Despite this, to date, Cantrell has received no reports of adverse events related to this recall.
Affected drug products include all lots distributed Feb. 16, 2017, through July 19, 2017, within the expiry. The drugs are packaged in a syringe or IV bag. Cantrell is notifying hospital facilities who received the products by email and phone, and is arranging for the return of all recalled products. Anyone with affected drug products should stop using them immediately and contact Cantrel to arrange return.
Any adverse events related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
In November 2016, Cantrell issued a recall of certain unexpired sterile drug products due to concerns of lack of sterility. That recall involved opioids including fentanyl and oxycodone, blood thinners like heparin, decongestants and muscle relaxers.
FDA Recall Notice