Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%...
FDA Recall #D-0297-2024 — Class I — November 13, 2023
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
Recalling Firm
Kilitch Healthcare India Limited — Navi Mumbai
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
10,944 bottles
Distribution
Nationwide within the United States
Code Information
All lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated