Drug product
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
D-0432-2024
Product summary
- Event
- Event 94275
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 187 cassettes
- Official record key
drug-enforcement:D-0432-2024
Official wording
Reason: Lack of Assurance of Sterility: leaking bags
Code information: Lot#: 20231020FEN-1, Exp: 04/17/2024
Distribution pattern: Nationwide within the U.S
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility