Drug product
Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1305-03
D-0142-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 148 milliliters
- Official record key
drug-enforcement:D-0142-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 04112018:37 Discard by: 10/1/2018; 06202018:70 Discard by: 12/16/2018; 08082018:95 Discard by: 2/4/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility