Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (...
FDA Recall #D-0291-2024 — Class I — November 13, 2023
Product Description
Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017
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
210,192 bottles
Distribution
Nationwide within the United States
Code Information
All lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated