Cardinal Health Recalls LEADER Brand Eye Drops Over Concerns of Eye Infections
THURSDAY, Nov. 2, 2023 – Cardinal Health, Inc. has issued a voluntary recall for certain LEADER brand eye drops after the U.S. Food and Drug Administration (FDA) uncovered unsanitary conditions at the manufacturing facility. The FDA notified the Dublin, Ohio-based company that investigators found bacteria in critical drug production areas of the facility.
The contaminated eye drops were supplied by Velocity Pharma, LLC and could potentially cause eye infections. Cardinal Health has warned that these infections, caused by bacteria, could result in partial vision loss or even blindness. The recalled products, which were supposed to be sterile, include LEADER Eye Irritation Relief, LEADER Dry Eye Relief, and LEADER Lubricant Eye Drops.
Cardinal Health has immediately ceased distributing the affected eye drops and is working to notify wholesalers, retailers, and consumers about the recall. The products in question were shipped to various locations beginning in December 2021.
According to the FDA recall notice, Cardinal Health has reported three adverse events related to the listed products. The company has also shared this information with its supplier. Consumers who have purchased any of the affected eye drops are advised to cease using them immediately and return them to the place of purchase.
To address any concerns or inquiries, individuals are encouraged to contact Sedgwick, Inc. by phone at 855-215-4940 between 8 am and 5 pm EST on weekdays or via email at [email protected]. Adverse events can be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.
The recall serves as a stark reminder of the potential risks associated with contaminated ophthalmic pharmaceuticals. When applied to the eyes, these products bypass some of the body’s natural defenses, making them particularly vulnerable to harm.
For more information on the recalled products, the FDA advises visiting their official website. Additionally, the U.S. National Library of Medicine offers further information regarding eye infections.
Source: U.S. Food and Drug Administration, news release, Nov. 1, 2023