Carolina Infusion, LLC — Class II: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes
Carolina Infusion, LLC has initiated a 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 affects Carolina Infusion, LLC, its compounding and manufacturing personnel, and healthcare providers or facilities utilizing these patient-specific injectable prescriptions.
A Class II recall for sterility assurance suggests that while the risk of serious adverse health consequences is not immediate, the processing environment or equipment failed to meet established standards for injectable products. The focus on 'processing equipment' indicates a potential vulnerability in the mechanical or automated aspects of the aseptic chain, which may necessitate a thorough root cause analysis of equipment maintenance or cleaning validation.
QA and Engineering teams should review the maintenance and validation status of all processing equipment involved in aseptic filling. Compounding facilities should verify that equipment cleaning and sterilization protocols are robust enough to meet sterility assurance levels for patient-specific injectable prescriptions.
Class II. Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.. Product: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, 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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