Agency classClass IIOur severity:High FDA (Drugs)·D-0243-2023·Announced 2023-02-01

FDA Recalls Voriconazole Ophthalmic Solution for Sterility Assurance Failure

Pharmacy Innovations is recalling Voriconazole 10mg/ml ophthalmic solution nationwide because FDA inspection found insanitary facility conditions that compromised product sterility assurance.

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 FDA Class II recall involves lack of sterility assurance in an ophthalmic product due to insanitary facility conditions identified during FDA inspection. No illnesses or injuries are reported. Because the hazard is theoretical with no reported harm, the severity rates as High.

Plain-English summary

Pharmacy Innovations, located in Erie, Pennsylvania, is recalling Voriconazole 10mg/ml ophthalmic solution distributed nationwide in the United States. This is a prescription eye-drop medication supplied in 10-milliliter dropper bottles with manufacturing code t20221025@32.

The FDA conducted an inspection of the manufacturing facility and found insanitary conditions. These conditions failed to assure sterility, which is a critical quality requirement for all ophthalmic products.

The recalled product was distributed nationwide. Patients and healthcare providers who have this product should contact Pharmacy Innovations or their pharmacy for guidance.

The recalled product

Product: VORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer: Pharmacy Innovations
Category: Drug — Ophthalmic Solution
Hazard: sterility-failure
contamination

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)

t20221025@32

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 · sterility failure