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FDA-Drug2026-04-15Class II

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

Fagron Compounding Services
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

Original summary

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 Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Lot: C274-000050858, Exp.:7/6/2026; C274-000051018, Exp.: 7/13/2026; C274-000049194, Exp.: 4/20/2026; C274-000049591, Exp.: 5/9/2026; C274-000049592, Exp.: 5/9/2026; C274-000049823, Exp.: 5/18/2026; C274-000050301, Exp.: 6/8/2026; C274-000050411, Exp.: 6/13/2026; C274-000051056, Exp.:7/18/2026. Distribution: Nationwide in the U.S.A. Affected quantity: 16,130 bags

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