Drug product
Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1311-03
D-0206-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 336 milliliters
- Official record key
drug-enforcement:D-0206-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 04102018:12 Discard by: 10/7/2018; 05102018:06 Discard by: 11/6/2018; 05222018:76 Discard by: 11/18/2018; 07022018:35 Discard by: 12/29/2018; 08272018:00 Discard by: 1/14/2019; 08082018:14 Discard by: 2/4/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility