Drug product
HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800
D-0734-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 vials
- Official record key
drug-enforcement:D-0734-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 11252019@27 Exp. 12/29/2019; 11272019@30 Exp. 12/31/2019; 12112019@16 Exp. 01/14/2020; 12062019@7 Exp. 01/09/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility