FDAFDA · Food and drugs·Recall number D-0662-2020
Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800
Published January 22, 2020 · Recall initiated: December 20, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of sterility assurance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Assurance Infusion
- Distributor
- Nationwide within the United States
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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