Drug product
BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
D-0690-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 syringe
- Official record key
drug-enforcement:D-0690-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 12102019@3 Exp. 12/19/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility