Drug product
QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800
D-0763-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 vials
- Official record key
drug-enforcement:D-0763-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 07012019@30 Exp. 12/28/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility