QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
FDA Recall #D-0766-2020 — Class II — December 20, 2019
Product Description
QUADMIX FORTE 30MG/4MG/40MCG/400MCG/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
134 vials
Distribution
Nationwide within the United States
Code Information
Lots: 07222019@10 Exp. 01/18/2020; 06242019@19 Exp. 12/21/2019; 08132019@15 Exp. 02/09/2020; 10292019@22 Exp. 04/26/2020; 11272019@24 Exp. 01/22/2020; 09182019@18 Exp. 03/16/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated