Apollo Care, LLC — Class II: SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx On
Apollo Care, LLC has initiated an ongoing Class II recall of Semaglutide 7.5mg/Glycine 7.5mg 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 dispensing this specific NDC (71170-721-01), and professional functions responsible for sterile injectable manufacturing and quality control.
The identification of nylon and silk-based particulates suggests a potential breach in cleanroom protocols, raw material purity, or equipment integrity. For sterile injectable products, particulate contamination poses a risk of vascular irritation or localized inflammatory reactions, which likely drove the Class II designation. This indicates that while the risk is not immediate or life-threatening (Class I), the product fails to meet essential quality and safety standards for subcutaneous administration.
QA and manufacturing teams should review filtration and container closure integrity protocols for sterile vials. Regulatory and compliance staff should monitor the 'Ongoing' status of this recall to ensure complete removal of affected lots and evaluate the effectiveness of current particulate matter inspection processes.
Class II. Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material. Product: SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01. Firm: Apollo Care, LLC (Columbia MO United States). Status: Ongoing.
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