Fagron Compounding Services Vancomycin HCL Class II Recall - Sterility Concerns
Summary
Fagron Compounding Services issued a voluntary Class II recall for Vancomycin HCL 1 gram in 0.9% Sodium Chloride Injection USP due to lack of assurance of sterility and a potential defect where the blue Break-Off-Part could detach from the administration port. The recall affects 11,680 bags distributed nationwide across seven lot numbers with expiration dates ranging from May to July 2026.
What changed
Fagron Compounding Services initiated a voluntary Class II recall for Vancomycin HCL 1 gram added to 250 mL 0.9% Sodium Chloride Injection USP (NDC 71266-5082-01) after identifying sterility assurance issues and a potential defect in the blue Break-Off-Part of the administration port. The recall covers seven lot numbers totaling 11,680 bags distributed nationwide, with the firm initiating recall on March 20, 2026 and FDA classifying the recall on April 7, 2026.\n\nHealthcare providers and pharmacies that received or dispensed this product should verify their inventory against the affected lot numbers (C274-000050987, C274-000049425, C274-000050069, C274-000050346, C274-000050698, C274-000050699, C274-000050775) and follow established recall response procedures. While the recall is voluntary, Class II designation indicates reasonably be expected to cause temporary or reversible adverse health consequences, making it important for affected parties to assess patient exposure and implement appropriate mitigation measures.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Fagron Compounding Services
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0442-2026 · 20260415 · Ongoing · Voluntary: Firm initiated
Product
Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
Reason for Recall
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Affected Lot Numbers / Codes
Lot: 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.
Quantity
11,680 bags
Firm Notification Method
Letter
Distribution
Nationwide in the U.S.A.
Initiated
20260320
FDA Classified
20260407
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