FDAClass IIFebruary 1, 2023

Gentamicin Bladder 0.08mg/ml recall: Sterility Concern

GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML…

Why was Gentamicin Bladder 0.08mg/ml recalled?

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

t20221117@11 t20221116@36 t20221011@36 t20221108@24 t20221125@30 t20221020@64

Product
GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML…
Recalling firm
Pharmacy Innovations
Quantity
N/A
Distribution
Nationwide in the USA
Recall date
February 1, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls