PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: February 14, 2024 Initiated: November 13, 2023 #D-0295-2024

Product Description

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 for Recall

Non-Sterility

Details

Units Affected
12,960 bottles
Distribution
Nationwide within the United States
Location
Navi Mumbai

Frequently Asked Questions

What product was recalled?
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. Recalled by Kilitch Healthcare India Limited. Units affected: 12,960 bottles.
Why was this product recalled?
Non-Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on February 14, 2024. Severity: Critical. Recall number: D-0295-2024.