REGULATORY INTELLIGENCE·Recall
Regeneron's EYLEA (Aflibercept) Recall: Sterility Concerns Impact Ophthalmic Supply Chain
Regeneron Pharmaceuticals, Inc. initiated a Class II recall for 405,725 prefilled syringes of EYLEA (aflibercept) due to sterility concerns and syringe breakage from its Tarrytown, NY facility. This voluntary, nationwide recall, D-0531-2024, highlights critical quality control vulnerabilities impacting supply chain integrity for a key ophthalmic biologic. Procurement and regulatory teams must assess current inventory and supplier quality agreements.
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