Sterling Pharmaceutical Services LLC — Class II: TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.
Sterling Pharmaceutical Services LLC has initiated a Class II recall of TRP The Relief Products Gentle Eyes Lubricant Eye Drops (Carboxymethylcellulose sodium 0.5%) due to a lack of assurance of sterility. The recall involves 15 mL bottles (NDC 17312-430-15) manufactured for TRP Company, Inc. and is currently classified as ongoing.
This affects Sterling Pharmaceutical Services LLC, TRP Company, Inc., and distributors or retailers stocking Gentle Eyes Lubricant Eye Drops. It impacts professionals in sterile manufacturing, quality control, and ophthalmic product distribution.
A Class II recall for lack of sterility assurance in an ophthalmic product indicates a potential risk of infection or adverse events, though not necessarily life-threatening. For regulatory professionals, this underscores the high level of scrutiny applied to sterile liquid fill operations and the critical importance of validated sterilization processes in eye care products. The involvement of both a manufacturer and a separate brand owner highlights potential liability and oversight risks in contract manufacturing relationships.
QA and supply chain teams should immediately verify if these specific NDC lots are in inventory and implement quarantine procedures. Regulatory teams should review contract manufacturing agreements to ensure sterility assurance protocols meet current standards for ophthalmic preparations.
Class II. Reason: Lack of Assurance of Sterility. Product: TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci Ln, Reno, NV 89502, NDC 17312-430-15.. Firm: Sterling Pharmaceutical Services LLC (Dupo IL United States). Status: Ongoing.
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