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