CLASS III Drug recall · Reported 26 May 2021 · FDA Enforcement Report
Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips recalled by Nomax
Nomax is recalling Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100, distributed nationwide in the US. The recall was initiated on 13 Apr 2021 and the FDA has classified it as Class III.
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-0387-2021
- FDA event ID
- 87695
- Recalling firm
- Nomax, Saint Louis, MO
- Brand
- Dry Eye Test
- Manufacturer
- Nomax Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Apr 2021
- FDA classified
- 18 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 13 Apr 2021 | Recall initiated by company | |
| 18 May 2021 | Classified by FDA | +35 days |
| 26 May 2021 | 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
Subpotent Drug
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
Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured by: Nomax, Inc, St. Louis, MO 63123, NDC: 51801-008-15
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
LOT 13336 EXP 07/23
Where was it sold?
Nationwide 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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 | Ful-glo, Fluorescein Sodium Ophthalmic Strips USP 1 mg recalled by Nomax | Nomax | Potency & Assay | Nationwide |
| Drug | CLASS II | GloStrips, Fluorescein Sodium Ophthalmic Strips recalled by NomaxGlostrips | Nomax | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip recalled | Nomax | Potency & Assay | Nationwide |
Other Fluorescein recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) recalledC20h10na2o5 Fluorescein Sodium Ophthalmic Strips | Wizcure Pharmaa Private | Sterility | 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 II | Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg recalled | Wells Pharmacy Network | Sterility | Nationwide |
| Drug | CLASS III | Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip recalledGlostrips | Nomax | Potency & Assay | Nationwide |