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Safety concerns regarding sterile compounded products from Cantrell Drug Company

by
Optum Workers' Comp
| Mar 14, 2018

The U.S. Food and Drug Administration (FDA) issued a warning to health care professionals and is urging consumers to stop using sterile products, including opioid products and other medications intended for sterile injection, produced by Cantrell Drug Company in Little Rock, Arkansas. According to the FDA, they are “concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk.” If compounded injectable products are not sterile and are prepared in non-sterile environments, administering the medications to patients can result in serious, possibly life-threatening infections.

In June 2017, the FDA inspected the company and found their compounding operating procedures to be unsanitary, raising public health concerns. In July, Cantrell voluntarily recalled all lots of unexpired sterile products, packaged in syringes or intravenous bags, at the hospital and consumer level due to lack of sterility assurance. At that time, the company notified its customers by email and phone and accepted all returned products. The recalled products were distributed to facilities in all states, except for Connecticut, Hawaii, South Carolina and Vermont. According to the FDA’s most recent safety alert, Cantrell stopped compounding sterile products at that time, but has since resumed production and distribution without demonstrating the identified concerns have been addressed.

In response to the FDA’s warning, Cantrell Drug Company filed a temporary restraining orderto prevent the FDA from shutting them down.

The FDA is urging health care providers to check their supplies immediately and not administer these products to their patients. If patients are not sure if they received any sterile products from Cantrell and have concerns, they should contact their providers.

According to our pharmacy relations department, this is a non-contracted pharmacy within our network and after further review, no prescriptions have processed through our network to date.

For more information about Cantrell Drug Company, please click here.

For more information from the FDA, please review the safety alerts listed below.

Sources:

  1. U.S. Food and Drug Administration. Safety Alerts for Human Medical Products. Compounded Drug Products from Cantrell Drug Company: FDA Warning - Serious Deficiencies in Quality and Sterility Assurance. March 2, 2018. Available at https://www.fda.gov/Safety/MedWatch/SafetyInformation/
    SafetyAlertsforHumanMedicalProducts/ucm599112.htm
    . Accessed March 2, 2018.
  2. U.S. Food and Drug Administration. Safety Alerts for Human Medical Products. Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance. July 25, 2017. Available at https://www.fda.gov/Safety/MedWatch/SafetyInformation/
    SafetyAlertsforHumanMedicalProducts/ucm568561.htm
    . Accessed March 2, 2018.
  3. Business Wire. Cantrell Drug Company Files for a Temporary Restraining Order against the FDA. March 1, 2018. Available at https://www.businesswire.com/news/home/20180301006529/en/Cantrell-Drug-Company-Files-Temporary-Restraining-Order. Accessed March 2, 2018.

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