Gentamicin Bladder Irrigation Solutions Recalled for Sterility Assurance Failure
Pharmacy Innovations is recalling Gentamicin bladder irrigation solutions due to FDA findings of insanitary facility conditions that compromised sterility assurance during manufacturing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for lack of sterility assurance in a compounded drug, representing a risk-of-harm product. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed contamination.
Plain-English summary
Pharmacy Innovations is recalling multiple lots of Gentamicin bladder irrigation solutions in various concentrations (0.08 mg/mL, 0.48 mg/mL, and 0.64 mg/mL) and volumes (25 mL, 30 mL, and 60 mL syringes). These prescription products were manufactured at a facility in Erie, Pennsylvania.
During an FDA inspection, insanitary conditions were identified at the manufacturing facility that created a lack of assurance of sterility for these products. This was classified as a Class II recall.
The recall affects products distributed nationwide in the USA. Patients and healthcare providers who have these products should not use them and should contact Pharmacy Innovations for instructions regarding return or disposal.
The recalled product
- Product
- 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,
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Compounded Injectable
- Hazard
- lack-of-sterility
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- t20221117@11 t20221116@36 t20221011@36 t20221108@24 t20221125@30 t20221020@64
Distribution
Distributed nationwide across the United States.
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