Drug product
HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10
D-0161-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 765 vials
- Official record key
drug-enforcement:D-0161-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 03262018:79 Discard by: 9/22/2018; 08212018:75 Discard by: 2/17/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility