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Recall Observatory FDA recall evidence

Drug product

fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.

D-0548-2026

May 12, 2026

Class II

Product summary

Firm
IntegraDose Compounding Services LLC
Event
Event 98991
Status
Ongoing
Classification
Class II
Quantity
376 cassettes
Official record key
drug-enforcement:D-0548-2026

Official wording

Reason: Subpotent Drug

Code information: Lot#: 20260310FEN-1, Exp. Date: 09/06/2026

Distribution pattern: Nationwide.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent