The U.S. Food and Drug Administration is alerting health care professionals and patients not to…
The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas.
These include opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide.
The agency is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.
FDA investigators most recently inspected Cantrell’s facility in June 2017, and observed poor compounding drug operations.
Of particular concern, the FDA investigators observed insanitary conditions and violations of current Good Manufacturing Practice (CGMP) that could cause Cantrell’s drugs to become contaminated or made injurious to health.
Because Cantrell produces drugs that are intended for sterile injection, the conditions identified – which can expose such products to contamination and render then unsterile – raise significant public health concerns.
In response to the FDA’s recommendation, in July 2017, Cantrell recalled all drug products marketed as sterile and ceased sterile compounding.
However, against FDA advice, the company resumed production and distribution without demonstrating that it had adequately addressed the problems identified.
How to Identify These Products
Products from the company can be identified by looking at the drug labels – which should include the company name, “Cantrell Drug Co.” Health care professionals should immediately check their medical supplies, quarantine any drug products from Cantrell Drug Company and not administer them to patients.
Examples of some of the drugs that Cantrell has compounded include opioids and common antibiotics. The FDA urges health care professionals who obtained products from Cantrell to make alternative arrangements to obtain medications they administer or dispense to patients from sources that adhere to proper quality standards.
Patients who have received any drug product produced by Cantrell and have concerns should contact their health care professional.
The FDA said it is not yet aware of reports of illness associated with the use of Cantrell’s products. Find out more at www.fda.gov.