Drug product
HCG 6000 unit/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06
D-0164-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 442 vials
- Official record key
drug-enforcement:D-0164-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 04092018:14 Discard by: 10/6/2018; 06042018:54 Discard by: 12/1/2018; 05292018:81 Discard by: 11/25/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility