FDA Recalls Intravenous Drugs Over Sterility Concerns
Recall issued for 30 lots of sterile products manufactured by Cantrell Drug Company.
The FDA announced that Cantrell Drug Company has recalled unexpired lots of their sterile products due to a lack of sterility assurance. These products were distributed to healthcare facilities from May to October of this year.
The use of a product intended to be sterile that has been contaminated could result in a serious, or life-threatening infection, the FDA reported in a press release. A majority of the 30 recalled products are intravenous drugs, which has the potential to cause severe adverse events if the contaminated product is administered.
Although there have been no reports of adverse events related to the recalled products thus far, discontinuing use of the products is an important step in preventing poor patient outcomes.
Cantrell Drug Company plans to contact individuals who purchased the affected products to inform them of the potential contamination, and arrange for the products to be returned.
For additional assistance, customers should call Cantrell Drug Company to discuss what should be done next. The FDA recommends that healthcare providers and patients report any adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting program.
“Because patient safety is our top priority, we immediately began addressing the issues raised and are working closely with health officials,” said Dell McCarley, Chairman and CEO of Cantrell Drug Company. “We have received no reports of injury or illness, and it’s important to note that all of our sterile products are tested for sterility before they are shipped. We deeply regret the impact this voluntary recall has on providers and patients, but our culture is one of safety first and we take absolutely no chances.”