CLASS II ONGOING Drug recall · Reported 1 May 2024 · FDA Enforcement Report
Ful-glo, Fluorescein Sodium Sterile Ophthalmic Strips recalled by Nomax
Nomax is recalling Ful-glo, Fluorescein Sodium Sterile Ophthalmic Strips USP 6 mg Fluorescein), 300 sterile, distributed nationwide in the US. The recall was initiated on 19 Apr 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Timeline
| 19 Apr 2024 | Recall initiated by company | |
| 23 Apr 2024 | Classified by FDA | +4 days |
| 1 May 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Ful-glo, Fluorescein Sodium Sterile Ophthalmic Strips USP 6 mg Fluorescein), 300 sterile recalled?
Yes. Nomax recalled Ful-glo, Fluorescein Sodium Sterile Ophthalmic Strips USP 6 mg Fluorescein), 300 sterile on 19 Apr 2024. The recall is Class II and its status is Ongoing. Recall number D-0464-2024.
Why was it recalled?
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Which lots are affected?
Lot 14842, Exp. 6/30/2024
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nomax
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | GloStrips, Fluorescein Sodium Ophthalmic Strips USP 0 mg recalledGlostrips | Nomax | Sterility | Nationwide |
| Drug | CLASS II | Ful-glo, Fluorescein Sodium Ophthalmic Strips USP 1 mg recalled by Nomax | Nomax | Sterility | Nationwide |
| Drug | CLASS II | GloStrips, Fluorescein Sodium Ophthalmic Strips USP 6 mg recalledGlostrips | Nomax | Potency & Assay | Nationwide |
| Drug | CLASS III | Dry Eye Test, Fluorescein Sodium recalled by NomaxDry Eye Test | Nomax | Sterility | Nationwide |
| Drug | CLASS III | Fluorescein Sodium Ophthalmic Strips USP, 0 mg per strip recalled | Nomax | Potency & Assay | Nationwide |