Cantrell Drug Co. of Little Rock, already in bankruptcy court for reorganization, was sued Thursday by federal regulators, who are asking for an injunction "to stop the manufacturing and distribution of adulterated drugs."
James L. McCarley Jr., CEO of the 66-year-old company, has responded by requesting a temporary restraining order to prevent the U.S. Food & Drug Administration from shutting down Cantrell Drug.
"My back is really against the wall," McCarley said in a news release. "The FDA has inspected us twice in the last year and voiced concerns about quality deficiencies that are strictly regulatory in nature and not in response to any product problem or patient illness.
"I couldn't be a stronger advocate for the safety of patients receiving our product."
The civil complaint that the U.S. Department of Justice filed on behalf of the FDA alleges that Cantrell Drug distributes products to interstate customers that "are prepared, packed, or held under insanitary conditions..."
Cantrell voluntarily recalled drugs in 2016 and 2017, according to the DOJ statement, which has a Washington dateline because the civil case is being handled by the department's Consumer Protection Branch. It also quotes Cody Hiland, U.S. Attorney for the Eastern District of Arkansas: "The Food, Drug, and Cosmetic Act is designed to protect patients from potentially unsafe drugs. This action demonstrates our commitment to enforcing these laws. We remain steadfast in our dedication to keeping the citizens of our communities safe by whatever means available under federal law.”
McCarley said in his announcement that experts he hired "concluded that we were operating under a state of sufficient quality control for release of safe product," and he suggested that his dispute with the FDA "is a communication problem -- not a compliance problem!"