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Recall Observatory FDA recall evidence

Drug product

norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02

D-0439-2026

March 20, 2026

Class II

Product summary

Firm
Fagron Compounding Services
Event
Event 98636
Status
Ongoing
Classification
Class II
Quantity
5140 bags
Official record key
drug-enforcement:D-0439-2026

Official wording

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

Code information: Lot: C274-000050004, Exp.: 4/24/2026; C274-000050295, Exp.:5/8/2026; C274-000050773, Exp.: 6/4/2026; C274-000051219, Exp.: 6/21/2026; C274-000051318, Exp.: 6/27/2026; C274-000051602, Exp.: 7/12/2026.

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility