LEADER Lubricant Eye Drops Recalled for Non-Sterility and Bacterial Contamination
Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops due to non-sterility issues. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility in India.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. Non-sterility in a sterile ophthalmic pharmaceutical product due to positive bacterial test results and insanitary manufacturing conditions represents a serious risk of bacterial infection, despite no illnesses reported yet.
Plain-English summary
Cardinal Health Inc. is recalling LEADER brand Lubricant Eye Drops (0.6% Propylene Glycol) 0.33 FL OZ (10 mL) sterile dropper bottles. The recall affects all lots of product (NDC 70000-0587-1) distributed nationwide in the USA. Approximately 8,784 bottles are involved.
The FDA identified non-sterility issues during an inspection of the manufacturing facility in India. Environmental sampling revealed insanitary conditions and positive bacterial test results, indicating that the product does not meet required sterility standards for safe ophthalmic use.
Consumers should discontinue use of this product immediately. Consumers with questions about the recall should contact their healthcare provider or pharmacist.
The recalled product
- Product
- LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Eye Care
- Affected units
- 8,784
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 6 recalled by Cardinal Health Inc. 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.
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