Carolina Infusion, LLC — Class II: QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, to
Carolina Infusion, LLC has initiated a Class II recall for Quad-Mix (papaverine, phentolamine, alprostadil, and atropine) injectable syringes due to a lack of assurance of sterility. The issue is specifically linked to processing equipment used during the production of these compounded products.
This affects Carolina Infusion, LLC, healthcare providers administering these compounded injectables, and clinical/quality personnel responsible for overseeing sterile compounding processes and equipment maintenance.
A lack of sterility assurance due to equipment issues indicates a potential breakdown in aseptic processing controls. For compounded sterile preparations, this creates a risk of microbial contamination. From a regulatory perspective, this suggests that the firm's equipment qualification or maintenance procedures may have been insufficient to ensure a validated sterile state during production.
Quality teams should verify that all processing equipment maintenance and sterilization protocols for compounded injectables meet current standards. A review of equipment-related sterility assurance protocols and batch records for compounded sterile preparations (CSPs) is recommended to identify potential vulnerabilities in the processing chain.
Class II. Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.. Product: QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. Firm: Carolina Infusion, LLC (Ridgeland SC United States). Status: Ongoing.
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