FDA: Don’t Use Cantrell Compounded Drug Products

The Food and Drug Administration yesterday alerted health care professionals and patients not to use drug products produced by Cantrell Drug Co., including opioid products and other drugs intended for sterile injection, citing serious deficiencies in the company’s compounding operations. “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,” said FDA Commissioner Scott Gottlieb, M.D. “This reckless activity threatens patient safety and will not be tolerated.” FDA has sought legal action to prevent the company from further producing and distributing drugs. It said health care professionals should immediately check their medical supplies, quarantine any drug products from the company and not administer them to patients. The agency is not aware of illness reports associated with the products, but asks health care professionals to report any associated adverse events or quality problems to its MedWatch program.