CLASS III Drug recall · Reported 29 Apr 2015 · FDA Enforcement Report
Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip recalled
Nomax is recalling Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as Ful-glo, distributed nationwide in the US. The recall was initiated on 24 Mar 2015 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-0963-2015
- FDA event ID
- 70552
- Recalling firm
- Nomax, Saint Louis, MO
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Mar 2015
- FDA classified
- 21 Apr 2015
- Reported
- 29 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 24 Mar 2015 | Recall initiated by company | |
| 21 Apr 2015 | Classified by FDA | +28 days |
| 29 Apr 2015 | 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 Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
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
Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode (01)00317478404019; packaged in 100-count strips per carton, (NDC 17478-404-01), UPC 3 17478 40401 9, Manufactured for: Akorn, Inc., Lake Forest, IL 60045.; and 2)Fluorescein Pro Glo Strips, individually wrapped strips, barcode (01)00360843000026, packaged in 300-count strips per carton, (NDC 60843-300-50), UPC 3 60843 30050 8, Manufactured for Eye Care and Cure by Nomax, Inc., St. Louis, MO 63123.
Where it was distributed
Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
Questions about this recall
Why was it recalled?
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Which lots are affected?
1) FUL-GLO Lot: 8980, Exp 10/15; 9081, Exp 01/16; 9088, Exp 02/16; 9128 and 9158, Exp 03/16; 2) Pro Glo Lot: 9082, Exp 01/17
Where was it sold?
Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
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.
Other products in this recall event
2 other products · FDA event 70552This product is part of a recall event; the main page for the event is Rose Bengal GloStrips (rose bengal) Ophthalmic Strips recalled by Nomax.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Rose Bengal GloStrips (rose bengal) Ophthalmic Strips recalled by NomaxGlostrips | Nomax | Potency & Assay | Nationwide | |
| CLASS III | Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip recalledGlostrips | 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 | 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 | Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips recalled by NomaxDry Eye Test | Nomax | Potency & Assay | Nationwide |