Drug product
LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800
D-0749-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 syringes/1 vial
- Official record key
drug-enforcement:D-0749-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 09172019@18 Exp. 03/15/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility