LEADER Lubricant Eye Drops Recalled Nationwide for Non-Sterility Concerns
LEADER brand Lubricant Eye Drops are being recalled nationwide due to non-sterility issues. FDA testing found insanitary conditions and positive bacterial contamination at the manufacturing facility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall involving non-sterility with confirmed bacterial contamination found in manufacturing facility environmental samples. Per severity rubric, FDA Class I recalls warrant minimum Severe classification.
Plain-English summary
Cardinal Health Inc. is recalling all lots of LEADER brand Lubricant Eye Drops (carboxymethylcellulose sodium 0.5%) distributed nationwide. The recall involves approximately 119,871 bottles of the 0.5 FL OZ (15 mL) dropper bottles.
The recall was initiated because the FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility in India. These findings indicate a non-sterility issue with the product.
Consumers should stop using this product immediately. Patients who have already used the drops should consult their healthcare provider if they have concerns about potential exposure.
The recalled product
- Product
- LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
- Brand
- LUBRICANT DROPS
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Eye Drops
- Hazard
- non-sterility
- bacterial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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FDA (Drugs) · 2023-11-29
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