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Recall Observatory FDA recall evidence

Drug product

Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

D-0021-2025

September 25, 2024

Class II

Product summary

Firm
Fresenius Kabi Compounding, LLC
Event
Event 95427
Status
Terminated
Classification
Class II
Quantity
4436 bags
Official record key
drug-enforcement:D-0021-2025

Official wording

Reason: cGMP violations

Code information: Lot # C274-000038801, exp. date 9-Oct-24 C274-000039045, exp. date 24-Oct-24 C274-000039240, exp. date 31-Oct-24

Distribution pattern: Product was distributed to 125 direct accounts nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP violations