POLYVINYL ALCOHOL, UNSPECIFIED Recall D-0131-2024
Description: LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1
POLYVINYL ALCOHOL, UNSPECIFIED Recall D-0131-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0131-2024 |
| Event ID | 93346 |
| Brand | EYES IRRITATION RELIEF |
| Generic Name | POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE |
| Manufacturer | POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA |
| Quantity | 11629 units |
| 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 | 70000-0087 |
| 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 | 532B59J990 FZ989GH94E |
| Drug Application Number | part349 |
| Structured Product Labeling (SPL ID) | c607e19d-2eb4-cb87-e053-2995a90ab785 |
| Structured Product Labeling (SPL Set ID) | bd2608c6-ffdf-352a-e053-2995a90a26a8 |
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