Drug product
PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding
D-1223-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 392 vials
- Official record key
drug-enforcement:D-1223-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: a) 01042226A2, Exp 4/4/2022; 01242228A2, Exp 4/24/2022; 02212208A1, Exp 5/22/2022; b) 01192230A2, Exp 4/19/2022; 02212217A1, Exp 5/22/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility