Carolina Infusion, LLC — Class II: TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes,
Carolina Infusion, LLC has initiated a Class II recall for Tirzepatide/Cyanocobalamin (26/2 mg/mL) injectable syringes due to a lack of sterility assurance. The issue is linked to the use of bacteriostatic water in the formulation and concerns regarding processing equipment used during compounding.
This affects Carolina Infusion, LLC, as well as healthcare providers and patients utilizing these compounded injectable syringes. It is relevant to sterile compounding pharmacists and quality assurance personnel responsible for aseptic processing.
A Class II recall for sterility concerns suggests that while the risk of serious adverse health consequences is not immediate, the product does not meet the necessary safety standards for injectable administration. The mention of processing equipment and formulation components (bacteriostatic water) indicates potential systemic issues in the compounding facility's aseptic controls or validated processes.
Review compounding formulations involving bacteriostatic water for compatibility with sterile injectable requirements and audit processing equipment cleaning and maintenance logs to ensure sterility assurance. Verify that all single-use syringe filling processes meet validated sterility standards.
Class II. Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.. Product: TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML 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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