Agency classClass IIOur severity:High FDA (Drugs)·D-0463-2024·Announced 2024-05-01

GloStrips ophthalmic drug recalled for active ingredient impurities

Nomax Inc is recalling GloStrips fluorescein sodium ophthalmic strips nationwide due to failure of the active pharmaceutical ingredient to meet USP standards for unspecified impurities.

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 with no reported illnesses or injuries. The hazard is a manufacturing-quality defect (impurities above USP standards), which poses theoretical risk to the safety or effectiveness of the ophthalmic drug but has not caused reported harm.

Plain-English summary

GloStrips fluorescein sodium ophthalmic strips (1.0 mg per strip, Rx only) are being recalled by manufacturer Nomax Inc due to a manufacturing defect in the active pharmaceutical ingredient. The product failed quality-assurance testing when the API was found not to be manufactured in compliance with the current USP monograph in regard to unspecified impurities.

The recall affects lot #14708 with an expiration date of April 30, 2024. Approximately 6,960 cartons were distributed nationwide. These ophthalmic strips are used by eye-care professionals for diagnostic eye procedures.

Healthcare providers and patients who received product from this lot should discontinue use and consult with a healthcare provider if they have concerns about their eye health. No illnesses or injuries related to this product have been reported to date. Consumers should dispose of recalled medication according to local guidelines or consult a pharmacist for proper disposal.

The recalled product

Product: GLOSTRIPS (FLUORESCEIN SODIUM)
Brand: GLOSTRIPS
Manufacturer: Nomax Inc
Category: Drug — Ophthalmic
Hazard: impurities
degradation
Affected units: 6,960

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 (2)

Lot #: 14708
Exp. 04/30/2024.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Nomax Inc 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 4 products in this recall →

Same brand · GLOSTRIPS

High
Ophthalmic Drug GloStrips Recalled for Active Ingredient Impurities
FDA (Drugs) · 2024-05-01
Low
Nomax Recalls Fluorescein Sodium Ophthalmic Strips for Packaging Degradation
FDA (Drugs) · 2015-04-29
Low
Nomax Recalls GLOSTRIPS Ophthalmic Strips for Packaging Degradation
FDA (Drugs) · 2015-04-29

Same manufacturer · Nomax Inc

See all →

Moderate
FUL-GLO Fluorescein Sodium Ophthalmic Strips Recalled for API Manufacturing Defect
FDA (Drugs) · 2024-05-01
High
FDA Recalls Fluorescein Sodium Ophthalmic Strips for Manufacturing Defect
FDA (Drugs) · 2024-05-01
Low
Nomax Recalls Subpotent Dry Eye Test Fluorescein Sodium Strips
FDA (Drugs) · 2021-05-26
Low
Nomax Recalls Fluorescein Sodium Ophthalmic Strips for Content Uniformity Issues
FDA (Drugs) · 2015-04-29

Same hazard · impurities