Drug product
Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm D Solutions, Houston, Texas
D-0144-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 vials
- Official record key
drug-enforcement:D-0144-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: a)04032018:49 Discard by: 9/30/2018; 05242018:72 Discard by: 11/20/2018; b) 06192018:08 Discard by: 12/16/2018; 06132018:29 Discard by: 12/10/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility