Drug product
Bacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas --- NDC 69699-1417-10
D-0140-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 285 vials
- Official record key
drug-enforcement:D-0140-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 07182018:12 Discard by: 1/14/2019; 04042018:68 Discard by: 9/30/2018; 05152018:57 Discard by: 11/10/2018; 06202018:17 Discard by: 12/17/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility