Drug Information Update – FDA alerts health care professionals not to use sterile drug products from Qualgen
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of lots 1 through 67 of non-expired drug products intended to be sterile produced and distributed nationwide by Qualgen LLC, in Edmond, Okla., due to lack of sterility and quality assurance. The recalled products were compounded prior to September 1, 2015.

Health care professionals should immediately check their medical supplies, quarantine any drug products marketed as sterile from Qualgen or Amerilab LLC, the facility’s former name, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

During FDA’s recent inspection of Qualgen’s facility, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Qualgen’s ability to assure the sterility of drug products that it produced.

On October 8, 2015, FDA recommended that Qualgen cease sterile operations until appropriate corrective actions have been implemented by the facility, and recall all non-expired drug products intended to be sterile. On October 9, 2015, Qualgen informed FDA that it would voluntarily recall certain lots of non-expired drug product marketed as sterile. However, the company refused to cease sterile compounding operations. Therefore FDA alerts health care professionals and patients not to use drug products marketed as sterile from Qualgen.

For more information, please visit: Qualgen

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