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Recall Observatory FDA recall evidence

Drug product

fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01

D-0225-2025

January 31, 2025

Class II

Product summary

Firm
Fagron Compounding Services
Event
Event 96232
Status
Completed
Classification
Class II
Quantity
1330 bags
Official record key
drug-enforcement:D-0225-2025

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot # C274-000040409, Exp 03/22/2025

Distribution pattern: Distributed in PA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility