Drug product
HCG 10,000 unit/0.3 gm Mannitol Lyopholized, Pharm D Solutions, Houston, Texas ---- NDC 69699-1711-10
D-0159-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1171 vials
- Official record key
drug-enforcement:D-0159-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 04182018:46 Discard by: 10/14/2018; 06072018:65 Discard by: 12/3/2018; 05082018:01 Discard by: 11/4/2018; 07282018:20 Discard by: 1/24/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility