FDAFDA · Food and drugs·Recall number D-0764-2020
QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial 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: 07012019@30 Exp. 12/28/2019; 08052019@13 Exp. 02/01/2020; 09252019@15 Exp. 03/23/2020; 10292019@12 Exp. 04/26/2020; 10092019@6 Exp. 03/04/2020; 10162019@12 Exp. 04/13/2020; 12042019@31 Exp. 01/18/2020; 12162019@35 Exp. 01/30/2020; 11262019@37 Exp. 05/24/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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