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Recall Observatory FDA recall evidence

Drug product

CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

D-0280-2023

December 27, 2022

Class II

Product summary

Firm
Sentara Infusion Services
Event
Event 91466
Status
Terminated
Classification
Class II
Quantity
71 bags total
Official record key
drug-enforcement:D-0280-2023

Official wording

Reason: Lack of sterility assurance

Code information: Beyond Use Date December 24-31, 2022

Distribution pattern: Dispensed to Patients Nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility