FDA: Don't use compounded drugs from Cantrell Drug Company
March 19, 2018
Health care professionals should not use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioids and antibiotics, because of "serious deficiencies" in the company's compounding operations, the U.S. Food and Drug Administration said in a March news release.
The FDA said it is concerned about Cantrell Drug Company's "processes to ensure quality and sterility assurance that put patient safety risk," according to the news release. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death, according to the FDA.
"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., in the March 1 news release. "This reckless activity threatens patient safety and will not be tolerated."
The FDA has sought legal action to prevent Cantrell from further production and distribution of drugs, it said in the release.
Drugs from the company can be identified by looking at the drug labels, which should include the company name, Cantrell Drug Co. The FDA urges health care professionals to check their medical supplies, quarantine any drugs from the company and not administer them to patients.
The FDA is not aware of reports of illness associated with Cantrell's products, it said in March, but health care professionals and consumers are asked to report adverse events or quality problems to FDA's MedWatch. Visit fda.gov/Safety/MedWatch