Carolina Infusion, LLC — Class II: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes
Carolina Infusion, LLC has initiated a Class II recall for Tri-MIX (Papaverine/Phentolamine/Alprostadil) 30/1/20 injectables due to a lack of assurance of sterility. The issue is specifically linked to processing equipment used during the production of these compounded single-use dosage syringes.
This recall affects Carolina Infusion, LLC, as well as personnel involved in sterile compounding, processing equipment maintenance, and quality oversight for injectable drug products.
A lack of sterility assurance in injectable products poses a significant risk for parenteral administration. The focus on 'processing equipment' suggests potential failures in equipment cleaning, sterilization validation, or maintenance protocols within the compounding environment. For regulatory professionals, this underscores the importance of environmental controls and equipment integrity in maintaining the safety of patient-specific prescriptions.
Quality and manufacturing teams should review maintenance and sterilization logs for all shared processing equipment. Documentation must demonstrate that processing steps effectively mitigate microbial contamination risks for patient-specific injectable dosages.
Class II. Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.. Product: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, 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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