MAY 08, 2013
The Compounding Shop of St. Petersburg, Fla. has voluntarily recalled all sterile products after an FDA inspection raised concern over sterility assurance. A representative of The Compounding Shop has told the Academy that its sterile products were only distributed to Florida-based health care providers.
The FDA investigators observed poor sterile production practices advised the firm that it is in the best interest of public health to take action to remove all sterile products from the market. The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers.
"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, MD, director, FDA's Center for Drug Evaluation and Research. "We do not have reports of patient infections. However, 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 FDA instructs health care providers to immediately check their medical supplies, quarantine and stop use of any sterile products from The Compounding Shop. The pharmacy is contacting all providers who have been supplied sterile products via letter and following up with phone calls to ensure receipt.
Any adverse events or side effects related to The Compounding Shop products should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
For more information, contact the Academy's Governmental Affairs Division at 202.737.6662