Drug product
Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1330-05
D-0197-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 milliliters
- Official record key
drug-enforcement:D-0197-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 08062018:52 Discard by: 10/5/2018; 08012018:08 Discard by: 9/30/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility