Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles — Class II: TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only,
Central Admixture Pharmacy Services (CAPS) initiated a Class II recall for a patient-specific TPN bag because the product did not contain insulin as specified on the label.
This affects pharmacy compounding organizations, specifically those providing outsourced admixture services, and clinical pharmacy staff responsible for verifying parenteral nutrition formulations.
Incorrect product formulation in parenteral nutrition suggests a potential failure in the compounding verification process or quality control checks. For high-alert medications such as insulin, omission can lead to glycemic management issues, indicating a need for more robust reconciliation between the prescription order and the finished preparation.
Review compounding batch records and verification steps for high-risk additives like insulin; verify that automated compounding devices or manual addition protocols include a second-person or independent system check before labeling.
Class II. Reason: Incorrect Product Formulation: product did not contain insulin as listed in the label.. Product: TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670. Firm: Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles (Santa Fe Springs CA United States). Status: Ongoing.
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