Cardinal Health recalls LEADER Lubricant Eye Drops (0.33 fl oz) due to non-sterility found at manufacturing facility. FDA detected bacterial contamination in environmental samples.
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Cardinal Health is recalling LEADER Lubricant Eye Drops (0.33 fl oz) because the FDA found bacterial contamination during environmental testing at the manufacturing facility. This poses a risk of infection if used.
The FDA found bacterial contamination in environmental samples at the manufacturing facility. This means the eye drops could contain harmful bacteria that might cause eye infections if used.
People who own or use LEADER Lubricant Eye Drops (0.33 fl oz) bottles. Those with eye conditions or frequent eye use are at slightly higher risk due to potential infection.
Check for LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%) in 0.33 fl oz (10 mL) dropper bottles. All lots were affected, as the product was distributed by Cardinal Health in India.
Look for LEADER Lubricant Eye Drops (0.33 fl oz) dropper bottles with NDC 70000-0587-1.
No, the FDA found bacterial contamination in environmental samples at the manufacturing facility, so these eye drops are not safe to use.
Check for LEADER Lubricant Eye Drops (0.33 fl oz) dropper bottles with NDC 70000-0587-1. All lots were affected.
The recall does not specify a remedy, so contact Cardinal Health for guidance.
We’ve drafted a message you can send LEADER to request your refund or repair — edit it as you like.
Subject: Recall D-0136-2024 — LEADER LEADER Hello, I own a LEADER that is covered by recall D-0136-2024 from LEADER. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
