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Recall Observatory FDA recall evidence

Drug product

TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0777-2020

December 20, 2019

Class II

Product summary

Firm
Assurance Infusion
Event
Event 84546
Status
Terminated
Classification
Class II
Quantity
10 vials
Official record key
drug-enforcement:D-0777-2020

Official wording

Reason: Lack of sterility assurance.

Code information: Lot: 08302019@4 Exp. 02/26/2020

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility