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FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company

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FDA issued a warning Thursday not to use drug products, including opioid products and other drugs intended for sterile injection, that were produced by Cantrell Drug Company of Little Rock, AR, and distributed nationwide.

FDA issued a warning Thursday not to use drug products, including opioid products and other drugs intended for sterile injection, that were produced by Cantrell Drug Company of Little Rock, AR, and distributed nationwide. The agency expressed concern about "serious deficiencies" in the company's compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk. FDA Commissioner Scott Gottlieb, MD, noted: "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. This reckless activity threatens patient safety and will not be tolerated." FDA is also pursuing legal action to prevent Cantrell from further producing and distributing drugs. In a preliminary injunction filed in the U.S. District Court in the Eastern District of Arkansas, the Department of Justice, in conjunction with FDA, called on the court to order Cantrell to discontinue manufacturing, processing, packing, labeling, holding, and/or distributing any drugs until the company complies with the federal Food, Drug, and Cosmetic Act and its implementing regulations. Also under the proposed order, Cantrell would be required to recall all non-expired drug products on the market. FDA said it is not yet aware of any reports of illness associated with the use of Cantrell's products. Any adverse events or quality issues with the products should be reported to FDA's MedWatch Adverse Event Reporting program.

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https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599089.htm

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