Drug product
HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
D-0743-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 syringes
- Official record key
drug-enforcement:D-0743-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 12112019@1 Exp. 12/20/2019; 12112019@6 Exp. 12/20/2019; 12162019@23 Exp. 12/25/2019; 12172019@7 Exp. 12/26/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility