TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800
FDA Recall #D-0773-2020 — Class II — December 20, 2019
Product Description
TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials 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
1290 vials
Distribution
Nationwide within the United States
Code Information
Lots: 07082019@29 Exp. 01/04/2020; 06252019@11 Exp. 12/22/2019; 07082019@29 Exp. 01/04/2020; 06252019@6 Exp. 12/22/2019; 07082019@28 Exp. 01/04/2020; 07262019@3 Exp. 01/22/2020; 07102019@13 Exp. 01/06/2020; 07162019@13 Exp. 01/12/2020; 07242019@15 Exp. 01/20/2020; 07162019@12 Exp. 01/12/2020; 08272019@11 Exp. 02/23/2020; 08162019@6 Exp. 02/12/2020; 07312019@14 Exp. 01/27/2020; 07262019@4 Exp. 01/22/2020; 08152019@9 Exp. 02/11/2020; 08162019@6 Exp. 02/12/2020; 08092019@6 Exp. 02/05/2020; 07312019@15 Exp. 01/27/2020; 08092019@5 Exp. 02/05/2020; 08272019@12 Exp. 02/23/2020; 09032019@36 Exp. 03/01/2020; 10012019@19 Exp. 03/30/2020; 09162019@15 Exp. 03/14/2020; 09162019@14 Exp. 03/14/2020; 09032019@35 Exp. 03/01/2020; 09032019@35 Exp. 03/01/2020; 09242019@15 Exp. 03/22/2020; 09112019@5 Exp. 03/09/2020; 10022019@15 Exp. 03/30/2020; 09112019@4 Exp. 03/09/2020; 10162019@16 Exp. 04/13/2020; 10282019@21 Exp. 04/25/2020; 10212019@20 Exp. 03/04/2020; 10162019@15 Exp. 04/13/2020; 10282019@22 Exp. 04/25/2020; 10242019@6 Exp. 03/04/2020; 10232019@25 Exp. 03/04/2020 Exp. 10082019@4 Exp. 04/05/2020; 10082019@5 Exp. 04/05/2020; 11262019@26 Exp. 01/10/2020; 12032019@12 Exp. 01/17/2020; 11262019@25 Exp. 01/10/2020; 10302019@24 Exp. 04/27/2020; 11262019@27 Exp. 01/10/2020; 10302019@23 Exp. 04/27/2020; 12032019@11 Exp. 01/17/2020; 11042019@10 Exp. 03/04/2020; 11042019@10 Exp. 03/04/2020; 11262019@24 Exp. 01/10/2020; 12042019@14 Exp. 01/18/2020; 12042019@15 Exp. 01/18/2020; 12102019@14 Exp. 01/24/2020; 12102019@13 Exp. 01/24/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated