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Company refuses to stop compounding operations despite FDA quality concerns, recall

During a recent inspection investigators observed insanitary conditions, including poor sterile production practices.

Qualgen is voluntarily recalling lots 1 through 67 of non-expired drug products intended to be sterile produced and distributed nationwide due to lack of sterility and quality assurance, according to the FDA.

However, the company is refusing to stop sterile compounding operations, despite FDA recommendations.

"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," according to a press release. "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."

During the 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.

To date, FDA is not aware of any adverse events associated with drug products made by Qualgen. The recalled products were compounded prior to Sept. 1, 2015.

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