Drug product
Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas
D-0191-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 609 vials
- Official record key
drug-enforcement:D-0191-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: a) 09062018:87 Discard by: 1/14/2019 b) 04042018:44 Discard by: 10/29/2018; 09022018:04 Discard by: 3/1/2019; 05212018:44 Discard by: 11/17/2018; 06122018:83 Discard by: 12/9/2018; 08132018:86 Discard by: 2/9/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility