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Recall Observatory FDA recall evidence

Drug product

MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic, Rx Only, use with home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

D-0303-2023

December 27, 2022

Class II

Product summary

Firm
Sentara Infusion Services
Event
Event 91466
Status
Terminated
Classification
Class II
Quantity
91 bags
Official record key
drug-enforcement:D-0303-2023

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