Drug product
Prostaglandin E1 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1623-05
D-0173-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 193 milliliters
- Official record key
drug-enforcement:D-0173-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 04262018:18 Discard by: 10/22/2018; 03292018:66 Discard by: 9/24/2018; 05312018:19 Discard by: 11/27/2018; 07022018:55 Discard by: 12/29/2018; 06122018:51 Discard by: 12/9/2018; 07242018:71 Discard by: 1/20/2019; 08302018:90 Discard by: 2/23/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility