FDA recalls Leader brand Lubricant Eye Drops nationwide for non-sterility
Leader brand Lubricant Eye Drops (0.6% Propylene glycol) are recalled nationwide due to non-sterility concerns. Consumers should discontinue use immediately.
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 recall. Per the severity rubric, Class I drug recalls carry a minimum severity level of 4 (Severe). No deaths, serious injuries, or hospitalizations are reported in the source text.
Plain-English summary
Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%) are subject to a Class I recall. The product, manufactured by Kilitch Healthcare India Limited and distributed by Cardinal Health in Dublin, Ohio, was available nationwide in 0.33 FL OZ (10 mL) bottles with NDC 70000-0587-1. Approximately 14,784 bottles with all lot numbers are affected.
The recall was initiated on November 13, 2023, due to non-sterility. Eye drops applied directly to the eye must be sterile to prevent contamination-related safety concerns.
Consumers with this product should discontinue use immediately. Those with questions should contact the manufacturer or the FDA.
The recalled product
- Product
- Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Ophthalmic / Eye Drops
- 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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