Drug product
Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800
D-0678-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 vials
- Official record key
drug-enforcement:D-0678-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 07302019@15 Exp. 01/29/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility