Eye Irritation Relief Drops Recalled Nationwide for Non-Sterility
Eye Irritation Relief drops are being recalled nationwide due to non-sterility. The FDA classified this as a Class I recall affecting 10,944 bottles distributed across all production lots.
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: The FDA classified this as a Class I drug recall, which establishes a minimum severity of Severe under the rubric. Non-sterility in an ophthalmic product represents a credible risk of contamination, though no illnesses or injuries have been reported.
Plain-English summary
Eye Irritation Relief is an over-the-counter ophthalmic (eye) drop product containing polyvinyl alcohol, povidone, and tetrahydrozoline hydrochloride. The product is packaged in 0.5 fl oz (15 mL) bottles and was distributed nationwide within the United States.
The product is being recalled due to non-sterility. Kilitch Healthcare India Limited voluntarily initiated this recall on November 13, 2023, which was classified as Class I by the FDA on February 5, 2024. Non-sterile ophthalmic products present a risk of contamination.
Approximately 10,944 bottles were affected, covering all production lots. Consumers who possess this product should discontinue use and contact a healthcare provider or the manufacturer for guidance. Return unused bottles to your pharmacy or contact Kilitch Healthcare India Limited for further instructions.
The recalled product
- Product
- EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
- Brand
- EYES IRRITATION RELIEF
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Ophthalmic
- Hazard
- non-sterility
- 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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