Drug product
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1365-10
D-0199-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 715 vials
- Official record key
drug-enforcement:D-0199-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 03292018:02 Discard by: 9/24/2018; 05302018:54 Discard by: 11/26/2018; 06062018:79 Discard by: 12/3/2018; 06122018:31 Discard by: 11/17/2018; 07252018:44 Discard by: 1/21/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility