Agency classClass IIOur severity:High FDA (Drugs)·D-0208-2023·Announced 2023-02-01

Flurbiprofen eye drops recalled for insanitary facility conditions

Pharmacy Innovations is recalling Flurbiprofen 0.04% ophthalmic solution nationwide due to insanitary conditions at the manufacturing facility that compromise product sterility.

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 without reported illnesses or injuries. The lack of sterility assurance in an ophthalmic product represents a risk-of-harm product where injury has not yet been reported, placing it at Score 3 (High) per the rubric.

Plain-English summary

Pharmacy Innovations is recalling Flurbiprofen 0.04% ophthalmic solution (eye drops) in 3-mL dropper bottles nationwide. The product code is t20221116@36.

The recall was initiated following an FDA inspection that revealed insanitary conditions at the manufacturing facility. These conditions raise concerns about the sterility of the product. Non-sterile eye drops can lead to serious eye infections and complications.

This product was distributed nationwide to healthcare facilities and pharmacies. Patients who have received this medication should contact their healthcare provider.

Consumers and healthcare providers who have this product should stop using it and contact Pharmacy Innovations or their healthcare provider for guidance on replacement or alternative medications.

The recalled product

Product: FLURBIPROFEN -CORN OIL- 0.04% (3ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer: Pharmacy Innovations
Category: Drug — Ophthalmic
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)

t20221116@36

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