Fluorescein Sodium Ophthalmic Strips USP — Class III drug recall D-0963-2015
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-0963-2015 |
|---|---|
| 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 | 62,691 cartons |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00317478404019, 00360843000026, 00360843300508 |
| NDC | 17478-0404-01, 60843-0300-50 |
| Lot numbers | 01/16, 01/17, 02/16, 03/16, 10/15, 8980, 9081, 9082, 9088, 9128, 9158 |
Product
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.
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-0963-2015. 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.