Fagron Compounding Services is recalling 11,680 bags of Vancomycin HCl 1 g in 250 mL 0.9% Sodium Chloride Injection. The recall is nationwide in the United States. The blue break-off part could detach from the administration port, raising sterility concerns. Stop using immediately and contact the provider for 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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This product is a compounded IV antibiotic prepared by a compounding pharmacy for clinical use. Healthcare settings rely on such products for sterile administration.
Break-Off-Part detachment could compromise sterility and introduce contaminants into IV administration.
This recall is not part of a broader industry pattern.
High urgency for healthcare facilities to review inventory, discontinue use, and contact the supplier for guidance.
FDA recall page D-0442-2026 and recall letter from Fagron Compounding Services.
Immediate action required; replacements or refunds arranged through recall notification.
Document lot numbers checked, dates, communications with supplier, and disposition of each bag.
Product: Vancomycin HCl 1 g added to 250 mL 0.9% Sodium Chloride Injection USP. Manufacturer: Fagron Sterile Services. Address: 8710 34th St. N. Wichita, KS 67226. NDC: 71266-5082-01. Distribution: Nationwide in the USA. Recall date: 2026-03-20. Report date: 2026-04-15. Status: Active. Quantity: 11,680 bags. Lot numbers and expirations include: C274-000050987 Exp. 7/12/2026; C274-000049425 Exp. 5/2/2026; C274-000050069 Exp. 5/30/2026; C274-000050346 Exp. 6/10/2026; C274-000050698 Exp. 6/27/2026; C274-000050699 Exp. 6/27/2026; C274-000050775 Exp. 7/4/2026.
No incident or injury counts are provided in the notice. The FDA listing indicates a Class II recall with a high hazard potential.
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