LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (1...
FDA Recall #D-0135-2024 — Class I — October 31, 2023
Product Description
LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1
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
11,782 bottles
Distribution
Nationwide in the USA
Code Information
ALL LOTS
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated