Fagron Compounding Services recalled 34,260 bags of Vancomycin HCI Injection across the United States. The recall cites lack of sterility assurance and a blue Break-Off-Part that could detach from the administration port. Healthcare providers and patients should stop using the product immediately and follow manufacturer guidance.
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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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Vancomycin HCI is an antibiotic administered intravenously. This recall involves a compounded sterile product prepared by Fagron Compounding Services for distribution nationwide.
A blue Break-Off-Part could detach from the administration port, potentially compromising sterile integrity and allowing contamination.
This recall is not described as part of a broader industry pattern in the provided data.
High risk for sterile administration products used in clinical settings; delays or substitutions may affect patient care.
FDA enforcement report D-0440-2026 and recall notification letters
Refunds/replacements coordinated by Fagron with healthcare facilities; timelines may vary by institution
Keep all recall notices, lot numbers, expiration dates, and correspondence with supplier
Brand: Fagron Compounding Services. Product: Vancomycin HCI, 1.25 g added to 250 mL, 0.9% Sodium Chloride Injection USP. NDC: 71266-5083-01. Quantity: 34,260 bags. Distribution: Nationwide in the USA. Lot numbers and expirations listed in the notice.
No specific injuries or incidents are documented in the provided recall notice.
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