PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: November 29, 2023 Initiated: October 31, 2023 #D-0136-2024

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.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
8,784 bottles
Distribution
Nationwide in the USA
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by Cardinal Health Inc.. Units affected: 8,784 bottles.
Why was this product recalled?
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 29, 2023. Severity: Critical. Recall number: D-0136-2024.