FDA alerts health professionals to potentially contaminated drug products The Food and Drug Administration (FDA) July 23 alerted health care professionals and consumers to a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd. of Temple, TX.
Health care professionals should immediately quarantine the products, which may be contaminated, and not administer them to patients, the agency said. Two recent FDA inspections of the company’s facility revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems and poor sterile production practices, the agency said.
At the FDA’s request, the company is ceasing sterile compounding operations until sufficient corrections are made. The agency asks health care professionals and consumers to report adverse events or quality problems associated with use of the products to the MedWatch program. Visit Med-Watch by clicking on: http://tinyurl.com/e4k98.
For more on the FDA’s announcement, click on: http://tinyurl.com/ou8wbs5.