Agency classClass IIOur severity:High FDA (Drugs)·D-0190-2023·Announced 2023-02-01

5-Fluorouracil Ophthalmic Solution Recalled for Sterility Assurance Concerns

Pharmacy Innovations is recalling 5-Fluorouracil 1% ophthalmic solution nationwide due to lack of sterility assurance. An FDA inspection found insanitary conditions at the manufacturing facility.

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 a risk-of-harm product (prescription ophthalmic medication requiring sterility) where no illnesses or injuries have been reported. The FDA Class II designation and confirmed facility sanitation violations create potential for contamination, but per the rubric, theoretical hazards without reported adverse events do not exceed score 3.

Plain-English summary

Pharmacy Innovations is recalling 5-Fluorouracil 1% ophthalmic solution nationwide. The recall affects all distribution of the product in 2.5ML and 5ML droptainers.

An FDA inspection of the manufacturing facility in Erie, Pennsylvania revealed insanitary conditions. As a result, the FDA determined there is lack of assurance of sterility for the affected product.

Patients and healthcare providers who have received this medication should contact Pharmacy Innovations or their pharmacy regarding the recall. Patients using the product should consult their healthcare provider before discontinuing use.

The recalled product

Product: 5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer: Pharmacy Innovations
Category: Drug — Ophthalmic
Hazard: lack-of-sterility
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)

t20221019@52 t20221013@13

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