FDAnews Drug Daily Bulletin

FDA Alerts Public Over Sterile Drugs from Oklahoma Compounder

Oct. 19, 2015

The FDA is warning healthcare providers and patients not to use sterile drugs made by an Oklahoma compounder after the firm refused to cease sterile operations following a failed inspection — the latest in a stream of safety alerts, warning letters and Form 483s having to do with compounders’ sterility practices over the past year.

According to the agency, a recent inspection of Qualgen’s compounding facility found unsanitary conditions. On Oct. 8, the FDA advised Qualgen to stop compounding sterile drugs until corrective actions were implemented. The next day, Qualgen began recalling 67 lots of drug compounded before Sept. 1 of this year, but rebuffed a request that it halt sterile drug production.

Last week’s safety alert follows one that was issued last week when a California compounder refused to recall possibly contaminated sterile drugs.

Qualgen is the third compounder to be asked to recall sterile drugs in the past month. In September, an Alabama compounder recalled its entire portfolio of drug products due to contamination issues. Lapses in sterility have also triggered 19 warning letters to compounders this year and a slew of 483s. — Kellen Owings