FDAFDA · Food and drugs·Recall number D-0663-2020
Autologous Serum 20% Eye Drops in 3 mL droppers 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: 12092019@33 Exp. 03/08/2020; 11112019@30 Exp. 02/09/2020; 10012019@17 Exp. 12/30/2019; 10162019@18 Exp. 01/14/2020; 10252019@11 Exp. 01/23/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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