HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800
FDA Recall #D-0735-2020 — Class II — December 20, 2019
Product Description
HCG 10,000U/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
2 vials
Distribution
Nationwide within the United States
Code Information
Lots: 12162019@38 Exp. 01/16/2020; 11272019@32 Exp. 12/31/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated