Cardinal Health Recalls LEADER Eyedrops Over Infection Risk: Important Information for Consumers
Cardinal Health, Inc. is voluntarily recalling specific LEADER brand eyedrops due to the potential risk of eye infections. The recall was initiated following an investigation by the U.S. Food and Drug Administration (FDA), which identified unsanitary conditions in Cardinal Health’s manufacturing facility. Tests conducted in critical drug production areas of the facility confirmed the presence of bacteria, which can lead to eye infections when introduced into the products.
Eye infections resulting from bacterial contamination could potentially cause partial vision loss or blindness, as noted in the recall notice issued by Cardinal Health. Eyedrop products were supposed to be sterile, and contaminated ophthalmic drug products pose a significant risk because they are applied directly to the eyes, bypassing some of the body’s natural defense mechanisms.
Cardinal Health has reported three adverse events associated with the recalled products and has shared this information with its supplier. The following LEADER brand eyedrops are part of the recall:
1. LEADER Eye Irritation Relief, NDC code 70000-0087-1
2. LEADER Dry Eye Relief, NDC code 70000-0088-1
3. LEADER Dry Eye Relief, NDC code 70000-0089-1
4. LEADER Lubricant Eye Drops, NDC code 70000-0090-1
5. LEADER Lubricant Eye Drops, NDC codes 70000-0090-2 (pack of 2) and 70000-0090-1 (bottle)
6. LEADER Lubricant Eye Drops, NDC code 70000-0587-1
These eyedrops are available over the counter and are commonly used for temporary relief from burning and irritation caused by dry eyes, to protect against further irritation, and to relieve redness.
The recalled products were distributed to wholesalers and retailers starting in December 2021. Cardinal Health is actively notifying its direct accounts about the recall via mail and making arrangements for the return of the affected products. Wholesalers, distributors, and retailers are advised to cease selling the recalled eyedrops, and consumers are urged to discontinue their use. Consumers can return any of the recalled products to the place of purchase.
If you experience signs or symptoms of an eye infection after using these products, it is recommended that you consult with your healthcare provider or seek immediate medical attention.
For inquiries related to the recall, you can contact Sedgwick, Inc. at 855-215-4940 on weekdays from 8 a.m. to 5 p.m. EST or via email at Cardinalhealth7720@sedgwick.com.
If you have experienced adverse events associated with these products or wish to report any such events, you can do so through the FDA’s MedWatch Adverse Event Reporting program, either online, by regular mail, or by fax.
Source:
• U.S. Food and Drug Administration, news release, Nov. 1, 2023
