Drug product
Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1308-03
D-0205-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 343 milliliters
- Official record key
drug-enforcement:D-0205-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 04102018:07 Discard by: 10/7/2018; 05102018:18 Discard by: 11/6/2018; 05222018:64 Discard by: 8/1/2018; 07022018:46 Discard by: 12/29/2018; 08012018:81 Discard by: 1/28/2019; 06202018:97 Discard by: 9/17/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility