Drug product
ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1
D-0896-2021
Product summary
- Event
- Event 88731
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,614 syringes
- Official record key
drug-enforcement:D-0896-2021
Official wording
Reason: Lack of sterility assurance.
Code information: Lot, expiry: Lot 20210803CEF-1, exp 09/17/2021; Lot 20210805CEF-3, 09/19/2021; Lots 20210806CEF-1, 20210806CEF-2, exp 09/20/2021; Lots 20210809CEF-1, 20210809CEF-2, exp 09/23/2021; Lot 20210810CEF-1, exp 09/24/2021; Lot 20210811CEF-1, exp 09/25/2021; Lot 20210812CEF-1, exp 09/26/2021
Distribution pattern: NH, MA, MN
Derived failure modes
-
Sterility assurance
Lack of sterility