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Recall Observatory FDA recall evidence

Drug product

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07

D-1302-2020

May 28, 2020

Class II

Product summary

Firm
QuVa Pharma, Inc.
Event
Event 85773
Status
Terminated
Classification
Class II
Quantity
648 bags
Official record key
drug-enforcement:D-1302-2020

Official wording

Reason: Subpotent drug - Product did not contain drug.

Code information: Lot#: 30010515

Distribution pattern: USA Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent