Drug product
BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
D-0691-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 syringe
- Official record key
drug-enforcement:D-0691-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 12172019@5 Exp. 12/26/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility