FDA Drug recall D-0295-2024
Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by…
- FDA Drug
- Class I
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class I recall of Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by… by Kilitch Healthcare India, citing non-Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0295-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-11-13 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Kilitch Healthcare India |
| Distribution | US |
Product
Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1
Reason
Non-Sterility
Identifiers
| ndc | 70000-0088-1 |
|---|---|
| code_info | All lots |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0295-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.