Agency classClass IIOur severity:High FDA (Drugs)·D-0240-2023·Announced 2023-02-01

Antibiotic Eye Drops Recalled for Sterility Assurance Failure

Pharmacy Innovations is recalling Tobramycin Fortified 15mg/mL Ophthalmic Solution nationwide due to insanitary facility conditions that compromised sterility assurance. Consumers should discontinue use and contact their healthcare provider.

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 of a sterile product where manufacturing quality failures compromised sterility assurance. While no confirmed contamination or reported illnesses are stated in the source, non-sterile eye solutions carry significant risk of infection. The score reflects the high-risk nature of the hazard despite the absence of reported adverse events.

Plain-English summary

Pharmacy Innovations is recalling Tobramycin Fortified 15mg/mL Ophthalmic Solution, a prescription antibiotic eye drop, nationwide. The product is identified by code t20221104@17 and was manufactured at the company's facility in Erie, Pennsylvania.

The FDA inspection revealed insanitary conditions at the manufacturing facility that compromised the assurance of product sterility. Non-sterile ophthalmic solutions pose a risk of infection when used in the eye.

Patients and consumers who have obtained this product should discontinue use immediately. Anyone who has used this product and experiences symptoms of eye infection—including redness, discharge, pain, or changes in vision—should contact their healthcare provider.

The recalled product

Product: TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer: Pharmacy Innovations
Category: Drug — Ophthalmic / Eye Drops
Hazard: sterility-failure
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)

t20221104@17

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