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Recall Observatory FDA recall evidence

Drug product

CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800

D-0724-2020

December 20, 2019

Class II

Product summary

Firm
Assurance Infusion
Event
Event 84546
Status
Terminated
Classification
Class II
Quantity
1 syringe
Official record key
drug-enforcement:D-0724-2020

Official wording

Reason: Lack of sterility assurance.

Code information: Lot: 12162019@21 Exp. 12/25/2019

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility