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Recall Observatory FDA recall evidence

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

September 17, 2021

Class II

Product summary

Firm
IntegraDose Compounding Services LLC
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

    reason.sterility_assurance · v1.0.0

    Lack of sterility