CARBOXYMETHYLCELLULOSE SODIUM Recall D-0134-2024
Description: LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle)
CARBOXYMETHYLCELLULOSE SODIUM Recall D-0134-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0134-2024 |
| Event ID | 93346 |
| Brand | LUBRICANT DROPS |
| Generic Name | CARBOXYMETHYLCELLULOSE SODIUM |
| Manufacturer | CARBOXYMETHYLCELLULOSE SODIUM |
| Original Package? | 1 |
| Active Substance | CARBOXYMETHYLCELLULOSE SODIUM |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA |
| Quantity | 28477 cartons |
| Recall Reason | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. |
| Drug Classification | Class I |
| Drug Code Info | 20231129 |
| Product NDC | 70000-0090 |
| Recall Initiation Date | 20231031 |
| Report Date | 20231129 |
| Classification Date | 20231201 |
| Address | 7000 Cardinal Pl Dublin, OH 43017-1091 United States |
| Recalling Firm | Cardinal Health Inc. |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | K679OBS311 |
| Drug Application Number | part349 |
| Structured Product Labeling (SPL ID) | c607e857-ab68-cf66-e053-2a95a90aee36 |
| Structured Product Labeling (SPL Set ID) | 1ac2fe24-9ff6-48c1-b123-fbc0e48f5304 |
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