Drug product
Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800
D-0663-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32 droppers
- Official record key
drug-enforcement:D-0663-2020
Official wording
Reason: Lack of sterility assurance.
Code information: 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
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility