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
- Affected units
- 14,784
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.
Part of a larger recall action
This product is one of 22 recalled by Kilitch Healthcare India Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
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