Drug product
Phenol 5% and Glycerin Aqueous Solution 10 mL Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1431-10
D-0170-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1139 milliliters
- Official record key
drug-enforcement:D-0170-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 05082018:59 Discard by: 11/4/2018; 08082018:57 Discard by: 2/4/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility