Agency classClass IIOur severity:High FDA (Drugs)·D-0232-2023·Announced 2023-02-01

Ophthalmic solution recalled for lack of sterility assurance

Pharmacy Innovations recalls a polyhexamethylene biguanide eye-drop solution nationwide due to insanitary manufacturing conditions. No illnesses have been reported.

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. While Class II recalls can be severe, this scores as High (3) because no hospitalization, serious injury, or illness reports are documented. Sterility assurance failures in ophthalmic solutions pose significant risk of ocular infection; however, without actual cases reported, the hazard remains theoretical per the rubric.

Plain-English summary

Pharmacy Innovations, located in Erie, Pennsylvania, is recalling a polyhexamethylene biguanide 0.2% ophthalmic solution (eye drops) in 10-ml dropper bottles with product code t20221025@32. The product was distributed nationwide and is available by prescription only.

An FDA inspection of the manufacturing facility discovered insanitary conditions that compromise the sterility assurance of the product. Ophthalmic solutions must be sterile to prevent microbial contamination, which could cause serious eye infections or other ocular complications.

This recall affects patients nationwide who received this medication from their pharmacies.

Patients currently using this medication should contact their pharmacy or healthcare provider immediately for guidance. Do not discontinue the medication without medical advice. Pharmacies should check whether their inventory is affected and provide patients with an alternative or replacement medication.

The recalled product

Product: POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer: Pharmacy Innovations
Category: Drug — Ophthalmic / Eye Drops
Hazard: lack-of-sterility
infection-risk

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 · lack of sterility