REGULATORY INTELLIGENCE·Recall
FDA Issues Class I Recall for Kilitch Healthcare's Non-Sterile Polyvinyl Alcohol Eye Drops
Kilitch Healthcare India Limited faces a Class I FDA recall for 1.49 million bottles of Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops due to non-sterility. This event, initiated November 13, 2023, highlights critical supply chain and quality control vulnerabilities for procurement and regulatory teams sourcing ophthalmic products from India, demanding immediate reassessment of supplier qualification and risk mitigation strategies.
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