Fagron Compounding Services recalls 109,320 sterile single-dose bevacizumab syringes nationwide due to lack of assurance of sterility. Healthcare providers and patients should stop using the product immediately. Contact Fagron Compounding Services or a healthcare provider for guidance. The recall was issued on 2025-08-29 and remains active as of 2025-09-24.
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact Fagron Compounding Services or your healthcare provider for guidance. Notification method: Letter
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Bevacizumab is a monoclonal antibody used in oncology as an anti-angiogenic agent. Compounded sterile syringes are prepared for hospital or clinic administration.
Lack of sterility assurance can lead to infections or contamination when injected, posing significant health risks.
This recall is not part of a broader industry pattern.
Immediate action required in clinical settings to prevent potential infections and ensure patient safety.
Recall notices and model numbers are available via the FDA enforcement page for D-0646-2025 and company communications.
Remedy processing timelines are set by the manufacturer and FDA; facilities should expect guidance on refunds or replacements through official notices
Keep recall notices, correspondences, and any affected lot records for compliance and patient safety
Brand: Fagron Compounding Services. Product: Bevacizumab (Avastin) Injection, 1.25 mg/0.05 mL (0.12 mL fill). Type: Sterile Single-Dose Syringe. Distribution: USA nationwide. Quantity: 109,320 syringes. Models involved: see listed model numbers.
No specific injuries or incidents are described in the provided data. The status is active with a high hazard classification.
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