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Recall Observatory FDA recall evidence

Drug product

TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

D-0317-2023

December 27, 2022

Class II

Product summary

Firm
Sentara Infusion Services
Event
Event 91466
Status
Terminated
Classification
Class II
Quantity
2 bags
Official record key
drug-enforcement:D-0317-2023

Official wording

Reason: Lack of sterility assurance

Code information: Beyond Use Date, ecember 24, 2022

Distribution pattern: Dispensed to Patients Nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility