Eye Drops Recalled for Non-Sterility Issues from Manufacturing Facility
Cardinal Health is recalling LEADER brand Eye Irritation Relief drops due to non-sterility concerns. FDA testing found insanitary conditions and positive bacterial results at the manufacturing facility, affecting 11,629 units distributed nationwide.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I designation triggers Critical severity per the rubric, which explicitly lists FDA Class I as meeting the highest severity threshold.
Plain-English summary
Cardinal Health Inc. is recalling LEADER brand Eye Irritation Relief, a sterile ophthalmic eye drop product containing polyvinyl alcohol 0.5%, povidone 0.6%, and tetrahydrozoline hydrochloride 0.05% (NDC 70000-0087-1). The 0.5 FL OZ (15 mL) dropper bottles were manufactured in India.
The FDA determined the product does not meet sterility requirements. During inspection of the manufacturing facility, the FDA identified insanitary conditions and positive bacterial test results from environmental sampling.
Approximately 11,629 units were distributed nationwide in the United States. All lots of the product are affected by this recall.
Consumers who have purchased this product should stop using it immediately and speak with their healthcare provider about alternative treatment options.
The recalled product
- Product
- EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
- Brand
- EYES IRRITATION RELIEF
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic / 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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