POLYETHYLENE GLYCOL 400 Recall D-0135-2024
Description: LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1
POLYETHYLENE GLYCOL 400 Recall D-0135-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0135-2024 |
| Event ID | 93346 |
| Brand | DRY EYE RELIEF |
| Generic Name | POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL |
| Manufacturer | POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL |
| Original Package? | 1 |
| Active Substance | POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA |
| Quantity | 11,782 bottles |
| 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 | 70000-0088 |
| 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 | B697894SGQ 6DC9Q167V3 |
| Drug Application Number | part349 |
| Structured Product Labeling (SPL ID) | c607d95b-ce97-7367-e053-2995a90ab847 |
| Structured Product Labeling (SPL Set ID) | f8da3af5-9172-4023-be82-0fd5bd891616 |
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