Leader Eye Drops were recalled due to a risk of severe infections from “insanitary conditions in the manufacturing facility” and reports of people who were injured.
Need a Texas Leader Eye Drops Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were diagnosed with a severe eye infection from eye drops, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Leader Eye Drop Recall
In November 2023, Cardinal Health issued a recall for Leader Eye Drops due to 3 reports of eye infections, which may lead to vision loss, blindness, and other life-threatening side effects.
What Happened?
Leader eye drops were recalled due to “insanitary conditions” in the manufacturing facility, according to the FDA. Inspectors also found positive bacteria test results in “critical drug production areas” where the eye drops were manufactured.
According to the FDA Safety Warning:
“There is a potential risk of eye infections that could result in partial vision loss or blindness. 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.”
Leader Eye Drops Linked to 3 Adverse Events
Cardinal Health received reports of 3 adverse events related to these listed products, the company said. Details about the injuries were not provided, but other eye drops made in the same facility were linked to an additional 3 reports of vision loss, blurry vision, and burning eyes.
What Leader Eye Drops Were Recalled?
The recall involves 6 types of Leader Eye Drops for eye irritation, dry eyes, and lubrication:
- LEADER™ Eye Irritation Relief: (Polyvinyl Alcohol,0.5%, Povidone, 0.6%, and Tetrahydrozoline Hydrochloride, 0.05%), 0.5 FL OZ bottle (15 mL), NDC 70000-0087-1
- LEADER™ Dry Eye Relief: (Carboxymethylcellulose Sodium, 1%), 0.5 FL OZ bottle (15 mL), NDC 70000-0089-1
- LEADER™ Lubricant Eye Drops: (Carboxymethylcellulose Sodium, 0.5%), 0.5 FL OZ bottle (15 mL), NDC 70000-0090-1
- LEADER™ Lubricant Eye Drops: (Carboxymethylcellulose Sodium, 0.5%), 2 bottles, 0.5 FL OZ (15 mL) each, NDC 70000-0090-2 (Carton) 70000-0090-1 (Bottle)
- LEADER™ Dry Eye Relief: (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%), 0.33 FL OZ bottle (10 mL), NDC 70000-0088-1
- LEADER™ Lubricant Eye Drops: (Propylene Glycol, 0.6%), 0.33 FL OZ bottle (10 mL), NDC 70000-0587-1
What is the Risk?
Eye drops must be sterile because they are applied directly to the eyes. Bacteria in the eye drops can cause a severe infection that permanently damages the eyes, resulting in vision loss, blindness, or deadly invasive infections that spread to the bloodstream or body.
Deadly Infection Outbreak Linked to Eye Drops
In early 2023, a deadly outbreak of eye infections was linked to EzriCare Artificial Tears, a brand of eye drops that was found to be contaminated with antibiotic-resistant Pseudomonas bacteria. At least 4 people died and 81 people in many states were infected from the eye drops.
Need a Leader Eye Drops Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.