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Lack of Sterility Assurance of Drug Products from The Compounding Shop of St. Petersburg, Florida Forces Recall


The FDA alerted health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Florida raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients.

 

At a recent inspection of The Compounding Shop, the investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of The Compounding Shop’s sterile drug products. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.

 

“If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Due to concerns about a lack of sterility assurance at the facility and out of an abundance of caution, we have advised the firm to remove its sterile products from the market to protect patients.” The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers.

 

Health care providers and hospital staff should immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients, and await further instructions from the company regarding the recalled products. Patients who have received any product produced by The Compounding Shop and have concerns should contact their health care provider.

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

See the FDA Safety Alert

 

 

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