Sterling Pharmaceutical Services LLC — Class II: Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile,
Sterling Pharmaceutical Services LLC has initiated a Class II recall for Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, due to a lack of assurance of sterility. The ongoing recall affects 0.5 FL OZ (15 mL) bottles distributed by Reliable-1 Laboratories LLC.
This recall affects Reliable-1 Laboratories LLC, Sterling Pharmaceutical Services LLC, and entities involved in the distribution and quality oversight of sterile ophthalmic drug products.
A lack of sterility assurance in ophthalmic products presents a significant regulatory risk, as these products are required to be sterile to prevent ocular infections. For regulatory professionals, this indicates a potential failure in aseptic processing or sterilization validation at the manufacturing site, which may necessitate a review of manufacturing controls and supplier oversight for sterile liquid fills.
QA and Supply Chain teams should verify if any current inventory is sourced from the affected facility and initiate quarantine procedures. Regulatory teams should review contract manufacturing sterility validation reports to ensure they meet current sterility assurance requirements.
Class II. Reason: Lack of Assurance of Sterility. Product: Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55.. Firm: Sterling Pharmaceutical Services LLC (Dupo IL United States). Status: Ongoing.
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