Drug product
Sterile Water 50 mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1421-50
D-0188-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 bags
- Official record key
drug-enforcement:D-0188-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 08092018:38 Discard by: 2/5/2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility