Sterling Pharmaceutical Services LLC — Class II: Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubri
Sterling Pharmaceutical Services LLC has initiated a Class II recall for Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%) distributed by Cameron Pharmaceuticals due to a lack of assurance of sterility. The recall involves 15 mL bottles (NDC 42494-448-05) and is currently classified as ongoing.
This affects Sterling Pharmaceutical Services LLC, Cameron Pharmaceuticals, LLC, and entities involved in the distribution, quality oversight, and clinical administration of ophthalmic lubricants.
A Class II recall due to lack of sterility assurance in an ophthalmic product indicates a potential risk of infection or injury, though the health consequences are typically temporary or reversible. For regulatory professionals, this suggests a breakdown in aseptic processing or sterility testing protocols at the manufacturing site, likely requiring a comprehensive root cause analysis and corrective actions to prevent recurrence.
QA and manufacturing teams should verify sterility assurance protocols for ophthalmic products and assess current inventories for NDC 42494-448-05. Regulatory departments should monitor the status of this ongoing recall to ensure proper reporting of any associated adverse events.
Class II. Reason: Lack of Assurance of Sterility. Product: Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05. Firm: Sterling Pharmaceutical Services LLC (Dupo IL United States). Status: Ongoing.
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