FDA Warns Against Products From The Compounding Shop - Florida May 08, 2013

medscape


Healthcare providers should not administer any products produced by The Compounding Shop of St. Petersburg, Florida, the US Food and Drug Administration (FDA) advised today.
During a recent inspection of the facility, FDA inspectors observed "poor sterile production practices that raise concerns about a lack of sterility assurance of The Compounding Shop's sterile drug products. Therefore, these products should not be administered to patients," according to the agency.
"If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
"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," she added.
The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers, the agency said.
The FDA advises healthcare providers and hospital staff to 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..........