FDA alerts doctors to stop administering compounded products


The Food and Drug Administration today alerted physicians to stop administering or providing drugs manufactured by Cantrell Drug, including opioid products and other drugs intended for sterile injection, because the company has failed to ensure quality and sterility in its compounding operations, which could seriously compromise patient safety.

Health care providers should check medical supplies and separate anything produced by Cantrell Drug, which can be identified by finding the company’s name on the label. The FDA also recommended that physicians seek alternative arrangements for medicines and that any patients who have any products made by Cantrell contact their physicians.

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The FDA has sought legal action against Cantrell to halt its production and distribution operations. The FDA raised serious concerns after an inspection in June 2017 revealed unsanitary conditions and violations of current Good Manufacturing Practice. This led to a recall and cessation of production of all sterile products; however, Cantrell resumed production and distribution against FDA advice.

So far, the FDA is not aware of any illness or injuries caused by potentially contaminated products from Cantrell, but any that do arise should be reported to the FDA’s MedWatch program.

Read more about this alert in the FDA website.

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