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Recall Observatory FDA recall evidence

Drug product

Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1

D-0015-2026

September 16, 2025

Class I

Product summary

Firm
IntegraDose Compounding Services LLC
Event
Event 97641
Status
Ongoing
Classification
Class I
Quantity
853/500 mL bags
Official record key
drug-enforcement:D-0015-2026

Official wording

Reason: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.

Code information: Lot #: 20250620OXY-1, Expiration date 10/18/2025

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent