QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
FDA Recall #D-0764-2020 — Class II — December 20, 2019
Product Description
QUADMIX 30MG/2MG/20MCG/100MCG/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
190 vials
Distribution
Nationwide within the United States
Code Information
Lots: 07012019@30 Exp. 12/28/2019; 08052019@13 Exp. 02/01/2020; 09252019@15 Exp. 03/23/2020; 10292019@12 Exp. 04/26/2020; 10092019@6 Exp. 03/04/2020; 10162019@12 Exp. 04/13/2020; 12042019@31 Exp. 01/18/2020; 12162019@35 Exp. 01/30/2020; 11262019@37 Exp. 05/24/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated