Apollo Care, LLC — Class II: SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous
Apollo Care, LLC has initiated a Class II recall for Semaglutide 2.25mg (0.9 mg/mL) sterile multi-dose vials due to the presence of particulate matter identified as nylon/polyamide and silk/proteinaceous-type material. The recall is currently classified as ongoing.
This recall affects Apollo Care, LLC, healthcare providers dispensing their injectable Semaglutide products, and professionals in sterile manufacturing, quality control, and clinical administration of subcutaneous medications.
The presence of foreign particulate matter in a sterile injectable product represents a significant breakdown in sterility assurance and manufacturing controls. The identification of specific fibers like nylon and silk suggests potential contamination during the filling, filtration, or gowning processes. Regulatory teams should consider this an indicator of potential systemic issues in environmental monitoring or material handling within the production facility.
Immediate assessment of current Semaglutide inventory for the specified NDC and lot is required. Quality teams should review filtration and container closure integrity processes to identify potential sources of nylon and silk contamination. Supply chain departments should ensure the affected sterile multi-dose vials are quarantined according to established recall procedures.
Class II. Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material. Product: SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02. Firm: Apollo Care, LLC (Columbia MO United States). Status: Ongoing.
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