LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, St...
FDA Recall #D-0136-2024 — Class I — October 31, 2023
Product Description
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1
Reason for Recall
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recalling Firm
Cardinal Health Inc. — Dublin, OH
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
8,784 bottles
Distribution
Nationwide in the USA
Code Information
ALL LOTS
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated