REGULATORY INTELLIGENCE·Recall
Asegua Therapeutics Initiates Class II Recall of Sofosbuvir and Velpatasvir Due to Packaging Defects
Asegua Therapeutics LLC, an affiliate of Gilead Sciences, faces a Class II FDA recall for 18,541 cartons of Sofosbuvir and Velpatasvir tablets. The issue stems from defective blister pack seals, causing loose tablets. This event necessitates immediate action for procurement, regulatory, and supply chain leaders to assess inventory, ensure patient safety, and review quality oversight for internationally manufactured critical medications.
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