Fluorescein Sodium Ophthalmic Strips USP — Class III drug recall D-0961-2015
Terminated recall by Nomax Inc, reported 2015-04-29, distributed nationwide. Failed Content Uniformity Specifications: The product may not meet finished product release specifications, in
| Recall number | D-0961-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nomax Inc, Saint Louis, MO, United States |
| Recall initiated | 2015-03-24 |
| Classified | 2015-04-21 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2017-02-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CO, DO, HN, IL, IS, JM, TT |
| Quantity | 23,201 cartons |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00317478403036, 00351801003012, 00351801003401, 00351801003500 |
| NDC | 17478-0403-03, 51801-0003, 51801-0003-01, 51801-0003-40, 51801-0003-50 |
| Lot numbers | 02/19, 05/19, 12/18, 9050, 9113, 9206 |
Product
Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-01), barcode (01)00351801003012, packaged in a) 100-count strips per carton (NDC 51801-003-40, UPC 3 51801 00340 1); and b) 300-count strips per carton (NDC 51801-003-50, UPC 3 51801 00350 0), Nomax, Inc., St. Louis, MO 63123 USA; and 2) FUL-GLO, individually wrapped strip (NDC 1748-403-03), barcode (01)00317478403036, packaged in 300-count strips per carton (NDC 17478-403-030, UPC 3 17478-403-03 6), Manufactured for: Akorn, Inc., Lake Forest, IL 60045.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0961-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.