Drug product
Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05
D-0194-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 vials
- Official record key
drug-enforcement:D-0194-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 04262018:09 Discard by: 10/22/2018; 07022018:48 Discard by: 12/29/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility