Drug product
Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1344-05
D-0204-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59 milliliters
- Official record key
drug-enforcement:D-0204-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 04262018:54 Discard by: 10/23/2018; 03292018:91 Discard by: 9/24/2018; 05312018:10 Discard by: 11/27/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility