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Priority review Enforcement Amended Final

Fagron Compounding Services Vancomycin HCL Class II Recall - Sterility Concerns

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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.

Published by FDA on changeflow.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

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, 2026

GovPing 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

Sources: openFDA · Raw JSON

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Last updated

Classification

Agency
FDA
Filed
April 15th, 2026
Instrument
Enforcement
Branch
Executive
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0442-2026

Who this affects

Applies to
Healthcare providers Pharmaceutical companies Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug compounding Pharmaceutical distribution Recall response
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Medical Devices Healthcare Product Safety

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