Drug product
Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas
D-0190-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 553 vials
- Official record key
drug-enforcement:D-0190-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: a) 04132018:97 Discard by: 10/10/2018; 04032018:25 Discard by: 9/30/2018; b) 04162018:29 Discard by: 10/11/2018; 03282018:80 Discard by: 9/24/2018; 06122018:06 Discard by: 12/9/2018; 08132018:55 Discard by: 2/9/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility