CLASS II ONGOING Drug recall · Reported 1 May 2024 · FDA Enforcement Report
Ful-glo, Fluorescein Sodium Ophthalmic Strips USP 1 mg recalled by Nomax
Nomax is recalling Ful-glo, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per, 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
- Recall number
- D-0465-2024
- FDA event ID
- 94461
- Recalling firm
- Nomax, Saint Louis, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Apr 2024
- FDA classified
- 23 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.
Where it was distributed
Nationwide in the USA
Questions about this recall
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 #: 14776, Exp. 05/31/2024.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 94461This product is part of a recall event; the main page for the event is GloStrips, Fluorescein Sodium Ophthalmic Strips recalled by Nomax.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | GloStrips, Fluorescein Sodium Ophthalmic Strips recalled by NomaxGlostrips | Nomax | Potency & Assay | Nationwide | |
| CLASS II | GloStrips, Fluorescein Sodium Ophthalmic Strips recalled by NomaxGlostrips | Nomax | Potency & Assay | Nationwide | |
| CLASS II | Ful-glo, Fluorescein Sodium Sterile Ophthalmic Strips recalled by Nomax | Nomax | Potency & Assay | Nationwide |
More recalls from Nomax
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ful-glo, Fluorescein Sodium Sterile Ophthalmic Strips recalled by Nomax | Nomax | Potency & Assay | Nationwide |
| Drug | CLASS II | GloStrips, Fluorescein Sodium Ophthalmic Strips recalled by NomaxGlostrips | Nomax | Potency & Assay | Nationwide |
| Drug | CLASS II | GloStrips, Fluorescein Sodium Ophthalmic Strips recalled by NomaxGlostrips | Nomax | Potency & Assay | Nationwide |
| Drug | CLASS III | Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips recalled by NomaxDry Eye Test | Nomax | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip recalled | Nomax | Potency & Assay | Nationwide |
Other Ful-glo recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ful-glo, Fluorescein Sodium Sterile Ophthalmic Strips recalled by Nomax | Nomax | Potency & Assay | Nationwide |