Drug product
HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800
D-0735-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 vials
- Official record key
drug-enforcement:D-0735-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 12162019@38 Exp. 01/16/2020; 11272019@32 Exp. 12/31/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility