REGULATORY INTELLIGENCE·Recall
FDA Class III Recall: Rising Pharmaceuticals' Timolol Maleate Ophthalmic Solution Labeling Error Exposes Supply Chain Vulnerabilities
Rising Pharmaceuticals, Inc. initiated a Class III recall for Timolol Maleate Ophthalmic Solution due to a critical labeling mix-up. A 0.25% strength bottle was incorrectly packaged in a 0.5% strength carton. This event, now terminated, underscores the imperative for robust quality control in pharmaceutical supply chains, particularly for products manufactured by FDC Limited in India and distributed nationwide across the U.S.
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