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Cardinal Health Recalls Leader Eye Drops Due to Infection Risk
Cardinal Health issued the eye drop recall after the company received information that an investigation had found unsanitary conditions in the products' manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility, according to an alert [1.]. issued by the U.S. Food and Drug Administration (FDA) on October 31, 2023.
"For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss or blindness," FDA said. "Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses. To date, Cardinal Health, Inc., and its subsidiaries have received reports of three (3) adverse events related to these listed products."
Which Products are Affected by the Leader Eyedrop Recall?
The following recalled products are sold over the counter (OTC) for temporary relief of burning and irritation due to dryness of the eye, for use as a protectant against further irritation or to relieve dryness of the eye, and/or to relieve redness of the eye due to minor eye irritations:
| Product Name | Package Description |
Brand Name |
NDC |
|---|---|---|---|
| Eye Irritation Relief (Polyvinyl Alcohol, 0.5%, Povidone, 0.6%, and Tetrahydrozoline Hydrochloride, 0.05%) |
0.5 FL OZ bottle (15 mL) |
LEADER™ | 70000-0087-1 |
| Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) |
0.5 FL OZ bottle (15 mL) |
LEADER™ | 70000-0089-1 |
| Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) |
0.5 FL OZ bottle (15 mL) |
LEADER™ | 70000-0090-1 |
| Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) |
2 bottles, 0.5 FL OZ (15 mL) each |
LEADER™ | 70000-0090-2 (Carton) 70000-0090-1 (Bottle) |
| Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%) |
0.33 FL OZ bottle (10 mL) |
LEADER™ | 70000-0088-1 |
| Lubricant Eye Drops (Propylene Glycol, 0.6%) |
0.33 FL OZ bottle (10 mL) |
LEADER™ | 70000-0587-1 |
These products were distributed to wholesalers and retailers across the U.S. beginning on Dec. 12, 2021.
Symptoms of an Eye Infection from Contaminated Eye Drops
- Blurry vision
- Discharge
- Pain or discomfort
- Redness of the eyelid or eye
- Feeling like there is something in the eye
- Increased sensitivity to light
Don't Buy These Eye Drops From Major Brands: News Nation Video
FDA Recommendation on Recalled Eye Drops
If you purchased any Leader eyedrops that are affected by this recall, you should stop using them immediately and return them to the point of purchase for a full refund. Wholesalers, Distributors, and Retailers that have the affected product that is being recalled should cease distribution of the products. Cardinal Health is notifying all affected direct accounts of the recall and is arranging for the return of all impacted items.
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The Product Liability Litigation Group at Schmidt & Clark, LLP national law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Leader Eye Drops Lawsuits. We are handling individual litigation nationwide and are currently accepting new legal challenges in all 50 states.
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