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.

Recall Number: D-0209-2023

Firm: Pharmacy Innovations

Classification: Class II

Status: Terminated

Report Date: 20230201

Initiation Date: 20221222

Termination Date: 20240731

Reason for Recall

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

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.