Drug product
Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-0912-20
D-0172-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1900 milliliters
- Official record key
drug-enforcement:D-0172-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 06252018:63 Discard by: 12/22/2018; 07312018:35 Discard by: 1/26/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility