Skip to content
Recall Observatory FDA recall evidence

Drug product

Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952

D-1072-2020

March 16, 2020

Class II

Product summary

Firm
The Medicine Shoppe Pharmacy
Event
Event 85234
Status
Terminated
Classification
Class II
Quantity
4 bottles
Official record key
drug-enforcement:D-1072-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 7016542, discard after 01/12/2021

Distribution pattern: Florida

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility