FDAnews Drug Daily Bulletin

FDA Releases Safety Notice Following Medaus’ Refusal to Recall Sterile Drugs

April 11, 2016

The FDA released a safety alert for sterile products made by an Alabama compounder after the pharmacy refused to recall unexpired drugs following a failed inspection — the latest in a stream of sterility issues affecting compounders.

A recent inspection of Medaus’ facility found poor sterile production practices. On March 22, the Alabama Board ordered the compounder to cease all sterile compounding practices.

A week later, the FDA advised Medaus to recall all unexpired drugs intended to be sterile; however, the firm has yet to recall its products. No adverse events linked to drugs produced by Medaus have been reported, the agency adds.