Agency classClass IIOur severity:High FDA (Drugs)·D-0209-2023·Announced 2023-02-01

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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.

Part of a larger recall action

This product is one of 59 recalled by Pharmacy Innovations under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 59 products in this recall →

Same manufacturer · Pharmacy Innovations

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Same hazard · lack of sterility