HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Recall #D-0743-2020 — Class II — December 20, 2019
Product Description
HYDROMORPHONE 2MG/ML INJ in 20 mL syringe 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
4 syringes
Distribution
Nationwide within the United States
Code Information
Lots: 12112019@1 Exp. 12/20/2019; 12112019@6 Exp. 12/20/2019; 12162019@23 Exp. 12/25/2019; 12172019@7 Exp. 12/26/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated