FDA-Drug2026-02-18Class II

vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59

Fresenius Kabi Compounding, LLC
Hazard
Lack of Assurance of Sterility
Sold states
US Nationwide.
Affected count
1578 bags
Manufactured in
20 Dan Rd, N/A, Canton, MA, United States
Products
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0336-2026

Original summary

vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59 Lack of Assurance of Sterility Lot # C274-000049628, Exp Date: 3-May-26. Distribution: US Nationwide. Affected quantity: 1578 bags

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