Facility recalls but won’t cease production of sterile products

The FDA alerted health care professionals and patients of a voluntary recall of sterile drug products from outsourcing facility Qualgen LLC. The compounding facility voluntary recalled lots 1 through 67 of non-expired drug products intended to be sterile produced due to lack of sterility and quality assurance. The FDA announcement urges health care professionals to check their medical supplies and quarantine any drug products marked as “sterile” from Qualgen or Americlab LLC (the former name of the facility). Although the facility has voluntarily recalled the products, it refuses to halt its sterile compounding operations.

Inspection

During an inspection of the Qualgen’s facility, the FDA discovered unsanitary conditions and poor sterile production practices. On October 8, 2015, the FDA recommended that the facility recall the sterile drug products at issue and cease production of sterile products until the conditions were improved. The next day, Qualgen informed the FDA that it would voluntarily recall the products but would not cease sterile compounding operations. Because the facility refused to stop production, the FDA is alerting health care professionals to not use Qualgen products marked sterile.

Reporting

There have not been any adverse events associated with sterile drug products made by Qualgen. The FDA suggests that patients who have received Qualgen products from a health care professional and are concerned about the risks associated with the products should contact their health care professional. The FDA also encourages patient reporting of any adverse events to the FDA MedWatch Adverse Event Reporting Program.