Medications & Supplements/Prescription Drugs

GloStrips and FUL-GLO Ophthalmic Strips Recalled for Quality Issues

Agency Publication Date: April 23, 2024

Summary

Nomax Inc is recalling 42,108 cartons of GloStrips and FUL-GLO (fluorescein sodium) ophthalmic strips because the active pharmaceutical ingredient (API) used to make them failed quality standards for impurities. These diagnostic strips were found to have unspecified impurities that do not meet current United States Pharmacopeia (USP) requirements. The recalled products were distributed nationwide to healthcare facilities and distributors.

Risk

Using ophthalmic strips with unspecified impurities can potentially cause irritation or unexpected adverse reactions in patients, though no specific injuries have been reported. This recall addresses a failure to meet legal purity and manufacturing standards for medical ingredients.

What You Should Do

This recall affects GloStrips and FUL-GLO (fluorescein sodium) Ophthalmic Strips USP, in 0.6 mg and 1.0 mg strengths, sold in cartons of 100 or 300 sterile strips.
Check the carton and individual strip packaging for NDC codes 51801-003-40, 51801-003-50, 51801-009-40, 17478-403-03, or 17478-404-01. See the Affected Products section below for the full list of affected codes.
Stop using the recalled diagnostic strips immediately.
Contact Nomax Inc or your medical supply distributor to arrange for the return of any remaining affected stock.
Healthcare providers should monitor patients for any adverse reactions or unexpected effects after use and report them to the manufacturer.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein)

Variants: 0.6 mg, 100 strips per carton, 300 strips per carton

Lot Numbers:

14904 (Exp. 06/30/2024)

14938 (Exp. 07/31/2024)

14931 (Exp. 06/30/2024)

NDC:

51801-003-40

51801-003-50

Rx Only diagnostic strips.

Product: GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein)

Variants: 1.0 mg, 100 Sterile Strips per carton

Lot Numbers:

14708 (Exp. 04/30/2024)

NDC:

51801-009-40

Rx Only diagnostic strips.

Product: FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein)

Variants: 0.6 mg, 300 sterile strips per carton

Lot Numbers:

14842 (Exp. 6/30/2024)

NDC:

17478-403-03

Manufactured for: Akorn, Inc.

Product: FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg

Variants: 1 mg, 100 sterile strips per carton

Lot Numbers:

14776 (Exp. 05/31/2024)

NDC:

17478-404-01

Manufactured for: Akorn, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94461

Status: Active

Manufacturer: Nomax Inc

Sold By: Akorn, Inc.; Nomax, Inc.

Manufactured In: United States

Units Affected: 4 products (15,056 cartons; 6,960 cartons; 4648 cartons; 15,444 cartons)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects GloStrips and FUL-GLO (fluorescein sodium) Ophthalmic Strips USP, in 0.6 mg and 1.0 mg strengths, sold in cartons of 100 or 300 sterile strips.

Check the carton and individual strip packaging for NDC codes 51801-003-40, 51801-003-50, 51801-009-40, 17478-403-03, or 17478-404-01. See the Affected Products section below for the full list of affected codes.

Stop using the recalled diagnostic strips immediately.

Contact Nomax Inc or your medical supply distributor to arrange for the return of any remaining affected stock.

Healthcare providers should monitor patients for any adverse reactions or unexpected effects after use and report them to the manufacturer.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Affected Products

Product: GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein)

Variants: 0.6 mg, 100 strips per carton, 300 strips per carton

Lot Numbers:

14904 (Exp. 06/30/2024)

14938 (Exp. 07/31/2024)

14931 (Exp. 06/30/2024)

NDC:

51801-003-40

51801-003-50

Rx Only diagnostic strips.

Product: GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein)

Variants: 1.0 mg, 100 Sterile Strips per carton

Lot Numbers:

14708 (Exp. 04/30/2024)

NDC:

51801-009-40

Rx Only diagnostic strips.

Product: FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein)

Variants: 0.6 mg, 300 sterile strips per carton

Lot Numbers:

14842 (Exp. 6/30/2024)

NDC:

17478-403-03

Manufactured for: Akorn, Inc.

Product: FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg

Variants: 1 mg, 100 sterile strips per carton

Lot Numbers:

14776 (Exp. 05/31/2024)

NDC:

17478-404-01

Manufactured for: Akorn, Inc.