Drug product
Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03
D-0143-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 115 milliliters
- Official record key
drug-enforcement:D-0143-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 04112018:50 Discard by: 10/7/2018; 08082018:53 Discard by: 2/4/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility