3/8/18

FDA Issues Warning for Sterile Injectables from Cantrell Drug Co.


By on 1:45 PM

The U.S. Food & Drug Administration (FDA) has issued a warning concerning drug products produced by Cantrell Drug Co.

The warning relates to opioid products and other drugs intended for sterile injection produced and distributed nationwide by the company.

In a safety alert, FDA notes, "The agency 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. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death."

During a June 2017 inspection, FDA investigators observed "poor compounding drug operations," according to the alert. Of particular concern were observations of insanitary conditions and violations of current Good Manufacturing Practice. Since Cantrell produces drugs intended for sterile injection, the conditions identified expose such products to contamination and render them unsterile.

In July 2017, Cantrell responded to a FDA recommendation by recalling all drug products marketed as sterile and ceased sterile compounding.

However, FDA notes that Cantrell went against its advice and resumed production and distribution without first demonstrating it had adequately addressed all problems identified.

Cantrell is based in Little Rock, Ark.
 

Phenelle Segal, RN, CIC, FAPIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years' experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.

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