Drug product
BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
D-0675-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 syringe
- Official record key
drug-enforcement:D-0675-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 12162019@2 Exp. 12/25/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility