Recall-Related Public Warnings Get Final US FDA Guidance
There may be fewer recalls, but they are getting more publicity, in part because of FDA warnings that one recalcitrant firm said “decimated” sales.
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FDA Warns Consumers Not To Use Sterile Drugs Made By Pacifico National After Firm Refuses Recall Requests
After Melbourne, Florida, outsourcer resisted entreaties to recall sterile drugs over contamination and eye infections, the FDA warned consumers not to use sterile drugs compounded by the firm, Pacifico National, doing business as AmEx Pharmacy.
Draft guidance outlines how manufacturers and distribution partners should prepare for, plan and conduct voluntary recalls of drugs and other FDA-regulated products.
Recent developments confirm the laser focus of the US FDA and the pharmaceutical industry on managing quality risks such as potentially carcinogenic impurities, product mix-ups and microbial contamination. But they also underscored opportunities like global regulatory harmonization, assay development and responses to negative pre-approval inspections.