FUL-GLO — Class II drug recall D-0464-2024
Ongoing recall by Nomax Inc, reported 2024-05-01, distributed nationwide. Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product i
| Recall number | D-0464-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nomax Inc, Saint Louis, MO, United States |
| Recall initiated | 2024-04-19 |
| Classified | 2024-04-23 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 4,648 cartons |
| Reason classes | specification failure |
| NDC | 17478-0403-03 |
| Lot numbers | 14842 |
| Expiration dates | 2024-06-30 |
Product
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.
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.
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-0464-2024. 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.