Drug product
Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800
D-0677-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 vials
- Official record key
drug-enforcement:D-0677-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 09192019@19 Exp. 03/17/2020; 08162019@5 Exp. 02/12/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility