FDA Drug Recalls

Recalls / Class II

Class IID-1072-2020

Product

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

Affected lot / code info
7016542, discard after 01/12/2021

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
The Medicine Shoppe Pharmacy
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
3524 B Tamiami Trl, N/A, Port Charlotte, Florida 33952-8100

Distribution

Quantity
4 bottles
Distribution pattern
Florida

Timeline

Recall initiated
2020-03-16
FDA classified
2020-03-31
Posted by FDA
2020-04-08
Terminated
2022-12-08
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1072-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls