GENTAMICIN BLADDER 0 recalled over sterility concerns

Recall date

December 22, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pharmacy Innovations recalls GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMI…

Recall number

D-0209-2023

FDA classification

Class II

Brand / firm

Pharmacy Innovations

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.