Drug product
ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1
D-0897-2021
Product summary
- Event
- Event 88731
- Status
- Terminated
- Classification
- Class II
- Quantity
- 589 bags
- Official record key
drug-enforcement:D-0897-2021
Official wording
Reason: Lack of sterility assurance.
Code information: Lot, expiry: 20210722CEF-2, exp 09/20/2021; 20210728CEF-1, exp 09/26/2021
Distribution pattern: NH, MA, MN
Derived failure modes
-
Sterility assurance
Lack of sterility