Central Admixture Pharmacy Services Inc — Class III: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Com
Central Admixture Pharmacy Services Inc. has initiated a Class III recall for a patient-specific Pediatric Total Parenteral Nutrition (TPN) bag due to an incorrect product formulation. The recall involves a 416.8 mL single-dose refrigerated injection compounded at their Norcross, Georgia facility.
This recall affects Central Admixture Pharmacy Services Inc., clinical staff administering pediatric parenteral nutrition, and pharmacy quality control departments responsible for oversight of compounded sterile preparations.
The classification as Class III suggests that while the formulation is incorrect, the FDA currently evaluates the risk of adverse health consequences as unlikely. However, for pediatric populations, formulation accuracy in TPN is critical for metabolic stability. The ongoing status of the recall indicates that mitigation and recovery efforts are currently in progress. Regulatory teams should note this as a potential signal of compounding process control issues.
Quality units should review compounding verification procedures for patient-specific formulations and ensure that final product checks are robust enough to detect formulation discrepancies prior to distribution. Clinical sites receiving these products should verify inventory against the specified lot/description and monitor for further communication from the manufacturer.
Class III. Reason: Incorrect Product Formulation. Product: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418. Firm: Central Admixture Pharmacy Services Inc (Norcross GA United States). Status: Ongoing.
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