Drug product
0.9% Sodium Chloride for Injection, 50 mL bags, Pharm D Solutions, Houston, Texas --- NDC 69699-1426-10
D-0187-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 bags
- Official record key
drug-enforcement:D-0187-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 04192018:13 Discard by: 10/16/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility