Do Not Use Sterile Qualgen Products, FDA Says

Recall affects products that were compounded prior to September 1, 2015.

The FDA has issued a warning to health care professionals and patients pertaining to sterile, non-expired products from Qualgen LLC, after investigators observed unsanitary conditions at the compounding company’s facilities.

Qualgen, based in Edmond, Oklahoma, is voluntarily recalling lots 1 through 67 of products intended to be sterile, stating that it cannot verify the sterility and quality of these products.

The recall affects products that 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,” the FDA wrote in its warning.

The FDA observed unsanitary conditions while recently touring Qualgen’s facilities, which raised concerns about the company’s right to assure sterility. The use of a product from Qualgen that is not sterile could result in serious or potentially life-threatening infections.

The FDA recommended that Qualgen cease all sterile compounding operations until it could correct its problems. However, the company refused to do so. Instead, Qualgen issued a voluntarily recall of some product lots. Because of the company’s decision, the FDA has now issued a warning to health care patients and professionals.

The FDA also stated it would work closely with the Oklahoma State Board of Pharmacy to protect public health. No adverse effects have been reported in association with Qualgen’s products.

However, the FDA is encouraging professionals and patients to report any adverse effects to the FDA’s MedWatch Adverse Event Reporting Program.