FDA Faced Resistance As It Pursued Recall At Registered Compounding Facility

Texas-based Unique Pharmaceuticals, an FDA-registered outsourcing facility, last week recalled all of its unexpired sterile products but only after initially sparring with FDA about whether the action was warranted. A drug safety advocate said the incident highlights the agency's need for mandatory drug recall authority because compounders may be more reluctant than their drug industry counterparts to voluntarily recall drugs. FDA requested the Unique Pharmaceuticals recall on July 11 following two inspections in the preceding months, according to a letter...

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