PlainRecalls
FDA Drug Critical Class I Ongoing

Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1

Reported: February 14, 2024 Initiated: November 13, 2023 #D-0297-2024

Product Description

Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1

Reason for Recall

Non-Sterility

Details

Units Affected
10,944 bottles
Distribution
Nationwide within the United States
Location
Navi Mumbai

Frequently Asked Questions

What product was recalled?
Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1. Recalled by Kilitch Healthcare India Limited. Units affected: 10,944 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-0297-2024.