2023-11-03 01:15:00
Key points. The U.S. Food and Drug Administration announced the latest in a series of recalls involving eye drops. The new recall concerns LEADER brand eye drops. FDA investigators They said they found unsanitary conditions at the facility where they are manufactured.
THURSDAY, Nov. 2, 2023 (HealthDay News) — Cardinal Health, Inc. is voluntarily recalling certain LEADER brand eye drops because they may cause eye infections. The U.S. Food and Drug Administration (FDA) ) informed the Dublin, Ohio, company that agency investigators found unsanitary conditions at its manufacturing facility. Tests of critical drug production areas of the facility came back positive for bacteria. The drops were supplied by Velocity Pharma, LLC. Possible eye infections caused by bacteria could lead to partial vision loss or blindness, Cardinal Health warned in a recall notice from the FDA. These products were required to be sterile. Contaminated ophthalmic pharmaceuticals pose a particular risk of harm because the products applied to the eyes bypass some of the body’s natural defenses. Cardinal Health has received reports of three adverse events related to these listed products and has shared this information with its supplier, the recall notice said. Several products are part of the recall. They are: LEADER Eye Irritation Relief, NDC code 70000-0087-1LEADER Dry Eye Relief, NDC code 70000-0089-1LEADER Lubricant Eye Drops, NDC code 70000-0090 -1LEADER Lubricant Eye Drops, NDC code 70000-0090-2 (2-pack) and 70000-0090-1 (bottle)LEADER Dry Eye Relief, NDC code 70000-0088-1LEADER Lubricant Eye Drops, NDC code 70000-0587-1
These eye drops are sold over the counter for temporary relief of burning and foreign body sensation caused by dryness, to protect against further irritation, and to relieve redness. They were shipped to wholesalers and retailers beginning in December 2021. While the company notifies to their direct mail accounts and arrange for the return of products, wholesalers, distributors and retailers should stop selling the eye drops. Consumers should also stop using them. You can return any recalled products to the place of purchase.Talk to your doctor or seek medical attention immediately if you have signs or symptoms of an eye infection.Contact Sedgwick, Inc. with questions by phone at 855-215-4940 of 8 am to 5 pm EST on weekdays, or by email at Cardinalhealth7720@sedgwick.com.Report adverse events to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.More InformationLearn more information on recalled products from the FDA. The U.S. National Library of Medicine has more information on eye infections. SOURCE: U.S. Food and Drug Administration, news release, Nov. 1, 2023
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