Drug product
QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800
D-0765-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 vials
- Official record key
drug-enforcement:D-0765-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 08132019@15 Exp. 02/09/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility