March 2 (UPI) -- The Food and Drug Administration on Friday warned health care professionals and patients not to use products made by Cantrell Drug Company and is attempting to stop the Arkansas company from distributing them.
Cantrell, based in Little Rock, Ark., provides sterile injectable pharmaceuticals that are primarily used in hospitals, including opioid products and others intended for sterile injection.
"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," the FDA said in a release. "Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death."
The FDA has also sought a preliminary injunction in the U.S. District Court in the Eastern District of Arkansas. The Department of Justice, in conjunction with the FDA, asked the court to order Cantrell to stop manufacturing, processing, packing, labeling, holding or distributing any drugs until the company complies with the Federal Food, Drug, and Cosmetic Act and its implementing regulations. Also, Cantrell will be required to recall all non-expired drug products on the market.
Cantrell, which was found in 1952, announced it has filed for a temporary restraining order to prevent the FDA from shutting down the company.
Dr. James L. McCarley, Jr., a pharmacist, found and CEO of Cantrell, said the FDA has twice inspected the company's facility in the last year, voicing concerns about quality deficiencies "that are strictly regulatory in nature and not in response to any product problem or patient illness."
"My back is really against the wall," Dr. James L. McCarley, Jr., a pharmacist, founder and CEO of Cantrell Drug Company, said in a statement. "I couldn't be a stronger advocate for the safety of patients receiving our product. Over the years, we've manufactured millions of drug doses delivered to hundreds of hospitals and helped save thousands of patients' lives. My honest desire is to do things right and fully comply with all the FDA's regulations. I've dedicated the last 12 months and most of my life's savings trying to satisfy the agency."
In June of last year, the FDA inspectors examined Cantrell's facility and said they observed poor compounding drug operations.
In July, Cantrell recalled all drug products marketed as sterile and ceased sterile compounding between Feb. 16 and July 19. But the company resumed production and distribution against FDA wishes without demonstrating that it had adequately addressed the problems identified.
On Nov. 7, Cantrell Drug filed for Chapter 11 Bankruptcy reorganization and is asking the Bankruptcy Court to protect the interests of its creditors for a grace period of at least 45 days as it hopes to negotiate a resolution with the FDA and continue its normal business operations.
"They want to shut us down for a third time in spite of everything we've done, and this time it will be the end of the company," he said. "We are a family-owned business, and we simply don't have the resources to continue to fight a bureaucracy that makes broad claims against us, gives little feedback, and ignores independent third-party experts. All this is at a snail's pace that would choke any small business."
He noted independent experts concluded the company was operating under a state of sufficient quality control for release of safe product. "As one expert summarized in his report to Cantrell, 'it appears there is a communication problem -- not a compliance problem!' '' he said.
Every month, Cantrell produces 80,000 morphine sulfate syringes, which are used to relieve severe pain and is on the FDA's drug shortage list.
"If Cantrell Drug shuts down, thousands of patients may not receive the pain medication they need and hospital pharmacists will be scrambling. All of this is in direct conflict with Congress' intent to provide a solution for drug shortages through 503B Outsourcing Facilities such as Cantrell," McCarley said.
The company also produces ephedrine sulfate, glycopyrrolate, lidocaine, neostigmine methylsulfate, norepinephrine bitartrate, phenylephrine, rocuronium bromide, succinylcholine chlorlide and vancomycin.
The FDA is advising healthcare professionals to "check their medical supplies, quarantine any drug products from Cantrell Drug Company and not administer them to patients."
Besides not using the products, the FDA wants to know about any adverse events or side effects related to the use of these products.
Cantrell Drug Company, according to its website, includes two divisions: a state-based custom compounding division primarily to "bridge the gap" with commercial product drug shortage and a FDA registered division know as an "Outsource Human Drug Compounder."