Drug product
Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding
D-1221-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 220 vials
- Official record key
drug-enforcement:D-1221-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: 11292109A2, Exp 5/28/2022, 01242202A1, Exp 6/18/2022; 03022214A1, Exp 8/29/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility