Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800
FDA Recall #D-0662-2020 — Class II — December 20, 2019
Product Description
Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials 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
60 vials
Distribution
Nationwide within the United States
Code Information
Lots: 09262019@13 Exp. 03/24/2020; 10072019@03/04/2020; 12062019@2 Exp. 06/03/2020; 12172019@12 Exp. 01/31/2020; 08142019@20 Exp. 02/10/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated