US FDA Warns Consumers Not to Use Products from Cantrell Drug Company

March 9, 2018: By Jon Swedien

The US FDA on March 1 warned health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas.

The American Society of Cataract and Refractive Surgery posted the FDA’s warning on its website.

The FDA said it 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.

“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,” FDA Commissioner Scott Gottlieb said in a press release announcing the warning. “This reckless activity threatens patient safety and will not be tolerated.”

The FDA, with the backing of the Department of Justice, has sought legal action to prevent the company from further producing and distributing drugs, the agency said.

The agency filed a preliminary injunction March 1 in the US District Court in the Eastern District of Arkansas that asked the court to order Cantrell to stop manufacturing, processing, packing, labeling, holding, or distributing any drugs until the company complies with federal law.

The proposed order also will require Cantrell to recall all non-expired drug products on the market, the FDA said.

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