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Recall Observatory FDA recall evidence

Drug product

TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0778-2020

December 20, 2019

Class II

Product summary

Firm
Assurance Infusion
Event
Event 84546
Status
Terminated
Classification
Class II
Quantity
20 vials
Official record key
drug-enforcement:D-0778-2020

Official wording

Reason: Lack of sterility assurance.

Code information: Lots: 07032019@12 Exp. 12/30/2019; 08212019@32 Exp. 02/17/2020; 10032019@12 Exp. 03/31/2020

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility