REGULATORY INTELLIGENCE·Warning Letter
Kilitch Healthcare India Limited Initiates Class I Recall of Non-Sterile Dry Eye Relief Ophthalmic Solution
Kilitch Healthcare India Limited initiated a Class I recall for 23,208 bottles of Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%) due to non-sterility. This voluntary action, impacting nationwide U.S. distribution, highlights critical supply chain vulnerabilities for ophthalmic products. Procurement and regulatory teams must reassess sterility assurance protocols and supplier qualification, particularly for contract manufacturing relationships involving high-risk sterile formulations.
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