Apollo Care, LLC — Class II: SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Inj
Apollo Care, LLC has initiated an ongoing Class II recall for Semaglutide 12.5mg (2.5mg/mL) 5 mL sterile multi-dose vials due to the presence of particulate matter identified as nylon/polyamide and silk/proteinaceous-type material.
This recall affects Apollo Care, LLC, healthcare providers administering this specific semaglutide formulation, and quality assurance personnel responsible for sterile injectable oversight.
The presence of particulate matter in a sterile injectable product represents a failure in sterility assurance and manufacturing controls. The identification of foreign materials like nylon and silk suggests potential issues with filtration systems, component cleaning, or environmental controls during the aseptic filling process, which may necessitate a thorough root cause analysis of the manufacturing environment.
Quality units should review sterile fill-finish procedures and component sourcing to prevent foreign material ingress. For affected batches, clinical sites must ensure immediate quarantine and follow standard reporting protocols for suspected product defects.
Class II. Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material. Product: SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05. Firm: Apollo Care, LLC (Columbia MO United States). Status: Ongoing.
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