Drug product
Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding
D-1193-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32 vials
- Official record key
drug-enforcement:D-1193-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: 01042221A2, Exp 3/5/2022; 02192216A1, Exp 4/20/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility