Drug product
HCG 4000 Unit Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1704-01
D-0162-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2737 vials
- Official record key
drug-enforcement:D-0162-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 03142018:73 Discard by: 3/9/2019; 04122018:64 Discard by: 4/7/2019; 07162018:84 Discard by: 7/11/2019; 06192018:36 Discard by: 6/12/2019; 08062018:28 Discard by: 8/1/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility