HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800
FDA Recall #D-0734-2020 — Class II — December 20, 2019
Product Description
HCG 1,000U/1ML INJ in 4 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
5 vials
Distribution
Nationwide within the United States
Code Information
Lots: 11252019@27 Exp. 12/29/2019; 11272019@30 Exp. 12/31/2019; 12112019@16 Exp. 01/14/2020; 12062019@7 Exp. 01/09/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated