GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRING...
FDA Recall #D-0209-2023 — Class II — December 22, 2022
Product Description
GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recalling Firm
Pharmacy Innovations — Erie, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide in the USA
Code Information
t20221117@11 t20221116@36 t20221011@36 t20221108@24 t20221125@30 t20221020@64
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated