FLUORESCEIN SODIUM Recall D-0462-2024
Description: GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.
FLUORESCEIN SODIUM Recall D-0462-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0462-2024 |
| Event ID | 94461 |
| Brand | GLOSTRIPS |
| Generic Name | FLUORESCEIN SODIUM |
| Manufacturer | FLUORESCEIN SODIUM |
| Original Package? | 1 |
| Active Substance | FLUORESCEIN SODIUM |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA |
| Quantity | 15,056 cartons |
| Recall Reason | 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. |
| Drug Classification | Class II |
| Drug Code Info | 20240501 |
| Product NDC | 51801-003 |
| Recall Initiation Date | 20240419 |
| Report Date | 20240501 |
| Classification Date | 20240423 |
| Address | 9735 Green Park Industrial Dr Saint Louis, MO 63123-7241 United States |
| Recalling Firm | Nomax Inc |
| Unique Ingredient Identifier | 93X55PE38X |
| Structured Product Labeling (SPL ID) | f63dc6e5-6c40-4731-be57-73860ea7a403 |
| Structured Product Labeling (SPL Set ID) | f5dbf66b-068d-4408-989b-4f29b3c48738 |
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