Skip to content
Recall Observatory FDA recall evidence

Drug product

TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0779-2020

December 20, 2019

Class II

Product summary

Firm
Assurance Infusion
Event
Event 84546
Status
Terminated
Classification
Class II
Quantity
45 vials
Official record key
drug-enforcement:D-0779-2020

Official wording

Reason: Lack of sterility assurance.

Code information: Lots: 10152019@23 Exp. 03/04/2020; 10302019@27 Exp. 04/27/2020; 08052019@19 Exp. 02/01/2020; 10032019@14 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