REGULATORY INTELLIGENCE·Recall
Zydus Pharmaceuticals Recalls Icosapent Ethyl Capsules Due to Oxidation and Leakage, Raising Supply Chain Quality Concerns
Zydus Pharmaceuticals (USA) Inc. has initiated a Class II recall of 11,616 bottles of Icosapent Ethyl Capsules 1 gram due to oxidation and leakage, resulting in burnt or melted capsules. This event, linked to manufacturer Doppel Farmaceutici s.r.l., highlights critical vulnerabilities in pharmaceutical quality control and supply chain integrity, demanding immediate attention from procurement and regulatory leaders.
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