FDA-Drug2026-04-15Class IIPROCESSING DEFECT

Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01

Nationwide distribution
Hazard

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Sold states
Nationwide in the U.S.A.
Affected count
16,130 bags
Manufactured in
8710 E 34th St N, Wichita, KS, United States
Products
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0441-2026

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