Sterling Pharmaceutical Services LLC — Class II: AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Steril
Sterling Pharmaceutical Services LLC has initiated a Class II recall for AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (Lubricant Eye Drops) due to a lack of assurance of sterility. The recall, which is currently ongoing, affects the 2-count twin pack (NDC 50268-068-02).
This affects Sterling Pharmaceutical Services LLC, the distributor AvKare, and quality, regulatory, and manufacturing professionals involved in the production and distribution of sterile ophthalmic solutions.
A Class II recall for lack of sterility assurance in an ophthalmic product suggests potential deviations in aseptic processing or sterilization validation. While the source does not detail specific contamination, such findings typically require a thorough investigation into environmental controls, media fills, or container-closure integrity. Regulatory teams may expect increased scrutiny of the manufacturing site's quality management system.
Quality units should verify the sterility assurance levels of current ophthalmic inventories and review environmental monitoring or sterilization validation data for products manufactured at the Dupo, IL facility. Supply chain teams should identify and quarantine affected NDC 50268-068-02 lots pending further instructions from the manufacturer.
Class II. Reason: Lack of Assurance of Sterility. Product: AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton). Firm: Sterling Pharmaceutical Services LLC (Dupo IL United States). Status: Ongoing.
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