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Recall Observatory FDA recall evidence

Drug product

Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01

D-0440-2026

March 20, 2026

Class II

Product summary

Firm
Fagron Compounding Services
Event
Event 98636
Status
Ongoing
Classification
Class II
Quantity
34,260 bags
Official record key
drug-enforcement:D-0440-2026

Official wording

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

Code information: Lot: C274-000050857, Exp.:7/6/2026; C274-000049316, Exp.: 4/26/2026; C274-000049367, Exp.: 4/28/2026; C274-000049496, Exp.: 5/3/2026; C274-000049518, Exp.: 5/4/2026; C274-000049535, Exp.: 5/5/2026; C274-000049653, Exp.: 5/11/2026; C274-000049654, Exp.: 5/11/2026; C274-000049745, Exp.: 5/16/2026; C274-000050128, Exp.: 5/31/2026; C274-000050151, Exp.: 6/1/2026; C274-000050184, Exp.: 6/6/2026; C274-000050504, Exp.: 6/15/2026; C274-000050662, Exp.: 6/21/2026; C274-000050836, Exp.: 7/5/2026; C274-000051014, Exp.: 7/13/2026; C274-000051057, Exp.: 7/18/2026; C274-000051240, Exp.: 7/25/2026.

Distribution pattern: Nationwide in the U.S.A.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility