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Recall Observatory FDA recall evidence

Drug product

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

D-0441-2026

March 20, 2026

Class II

Product summary

Firm
Fagron Compounding Services
Event
Event 98636
Status
Ongoing
Classification
Class II
Quantity
16,130 bags
Official record key
drug-enforcement:D-0441-2026

Official wording

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

Code information: 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 pattern: Nationwide in the U.S.A.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility