The Food and Drug Administration (FDA) is warning patients and providers not to use drug products compounded by Cantrell Drug Company in Little Rock, Arkansas.
The FDA’s communication expressed concerns about serious deficiencies in the Company’s compounding operations, including sterility and quality issues that may put patients at risk. Receipt of contaminated or low-quality drugs can cause serious and life-threatening injury or death. An FDA inspection in June 2017 revealed poor compounding operations, including unsanitary conditions and violations of current Good Manufacturing Practice (cGMP) that could lead to potential contamination or health risks.
In response, Cantrell recalled all drug products marketed as sterile and stopped sterile compounding in July 2017. However, the Company restarted production and distribution before demonstrating resolution of the identified problems.
“Despite the FDA’s concerns about egregious conditions observed at Cantrell’s facility, during several inspections, with the most recent in 2017, the company continued to compound and distribute drugs without adequately addressing their potentially dangerous conditions. This reckless activity threatens patient safety and will not be tolerated,” said FDA Commissioner Scott Gottlieb, MD.
A preliminary injunction filed today asks the court to order Cantrell to stop manufacturing, processing, packing, labeling, holding, and/or distributing any drugs until the Company complies with regulations. The order also requires the Company to recall all non-expired drugs from the market.
Healthcare professionals should check their medical inventory and quarantine any drug products with the name “Cantrell Drug Co.” Compounded products by Cantrell include opioids, antibiotics, and other drugs intended for sterile injection.
For more information call or visit FDA.gov.