IntegraDose Compounding Services LLC — Class II: fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDos
IntegraDose Compounding Services LLC has initiated a Class II recall for Fentanyl Citrate Sterile CADD for Injection due to the product being subpotent. The recall involves NDC 71139-6030-1 and remains in ongoing status.
This affects IntegraDose Compounding Services LLC, healthcare facilities utilizing their sterile compounding services, and clinical staff responsible for managing CADD injection systems.
A subpotent designation for a controlled substance used in pain management suggests potential failures in the compounding process, stability testing, or potency verification. Regulatory teams should view this as a signal to audit compounding logs and analytical testing procedures to mitigate the risk of therapeutic failure in sterile injectables.
Pharmacy and QA teams should immediately identify and sequester any remaining inventory of the specified NDC. Regulatory departments should review compounding batch records and potency testing protocols to ensure stability and dosing accuracy for sterile injectable products.
Class II. Reason: Subpotent Drug. Product: fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.. Firm: IntegraDose Compounding Services LLC (Shoreview MN United States). Status: Ongoing.
Open in openFDA / FDA.gov