Carolina Infusion, LLC — Class II: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes,
Carolina Infusion, LLC has initiated an ongoing Class II recall for Tri-MIX (Papaverine/Phentolamine/Alprostadil) injectable syringes due to a lack of assurance of sterility. The issue is specifically linked to the processing equipment used during the compounding of the product.
This recall affects Carolina Infusion, LLC, healthcare providers utilizing compounded Tri-MIX injectables, and professionals involved in sterile compounding, quality control, and pharmacy operations.
A lack of sterility assurance in injectable products represents a significant clinical risk, potentially leading to infections. From a regulatory perspective, this suggests a failure in the maintenance, cleaning, or validation of compounding equipment, which may indicate systemic gaps in the firm's sterile processing controls or Quality Management System.
Sterile compounding facilities should review equipment maintenance and validation logs to ensure processing hardware does not compromise sterility. QA teams should verify that environmental monitoring and equipment cleaning protocols are sufficient to mitigate contamination risks during the fill-finish process for single-use syringes.
Class II. Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.. Product: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, 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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