TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
FDA Recall #D-0776-2020 — Class II — December 20, 2019
Product Description
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Reason for Recall
Lack of sterility assurance.
Recalling Firm
Assurance Infusion — Houston, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
358 vials
Distribution
Nationwide within the United States
Code Information
Lots: 08082019@7 Exp. 02/04/2020; 08232019@1 Exp. 02/19/2020; 07262019@12 Exp. 01/22/2020; 07012019@25 Exp. 12/28/2019; 07102019@14 Exp. 01/06/2020; 09202019@4 Exp. 03/18/2020; 10282019@23 Exp. 04/25/2020; 10092019@7 Exp. 03/04/2020; 08292019@11 Exp. 02/25/2020; 10042019@6 Exp. 04/01/2020; 10162019@20 Exp. 04/13/2020; 11062019@24 Exp. 03/04/2020; 12042019@20 Exp. 01/18/2020; 12102019@11 Exp. 01/24/2020; 12162019@36 Exp. 01/30/2020; 11262019@29 Exp. 01/10/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated