Drug product
HCG 50,000 unit/0.3 gm Mannitol Lyophilized Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50
D-0163-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 114 vials
- Official record key
drug-enforcement:D-0163-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 04092018:36 Discard by: 10/6/2018; 05292018:93 Discard by: 11/25/2018; 08062018:96 Discard by: 2/2/2019; 07022018:64 Discard by: 7/6/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility