Drug product
Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1310-03
D-0192-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67 milliliters
- Official record key
drug-enforcement:D-0192-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 05072018:35 Discard by: 11/3/2018; 06122018:01 Discard by: 12/9/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility