Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company — Class II: Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoli
Insight Pharmaceuticals LLC has initiated a Class II recall for Clear Eyes Redness Relief eye drops (0.5 fl oz) due to a lack of assurance of sterility. The recall remains ongoing and affects products distributed under NDC 67172-797-15.
This recall affects Insight Pharmaceuticals LLC, its parent company Prestige Consumer Healthcare, and distributor Medtech Products Inc., as well as QA, compliance, and supply chain professionals managing sterile OTC ophthalmic products.
A lack of assurance of sterility in ophthalmic products presents a significant regulatory risk as these products are required to be sterile to prevent ocular infections. While the source does not specify a confirmed contamination event, the 'lack of assurance' designation suggests potential deviations in aseptic processing or container closure integrity, which typically necessitates a thorough investigation into manufacturing controls and sterilization validation.
Quality teams should verify the sterility assurance levels of existing ophthalmic inventory and review environmental monitoring or fill-finish data for the specific NDC identified. Regulatory and supply chain teams must coordinate to manage the ongoing status of the recall and assess impact on downstream distribution.
Class II. Reason: Lack of Assurance of Sterility. Product: Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15. Firm: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company (Tarrytown NY United States). Status: Ongoing.
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