FDAFDA · Food and drugs·Recall number D-0209-2023
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.
Published February 1, 2023 · Recall initiated: December 22, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Pharmacy Innovations
- Distributor
- Nationwide in the USA
- Lot
- t20221117@11 t20221116@36 t20221011@36 t20221108@24 t20221125@30 t20221020@64
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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