TOPIC: Certain Eye Drops by LEADER: Recall - Due to Potential Risk of Eye Infections
AUDIENCE: Consumer, Health Professional, Ophthalmology, Pharmacy
ISSUE: Cardinal Health is recalling all lots of ophthalmic products supplied by Velocity Pharma because Cardinal Health received information from FDA indicating investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.
Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss or blindness. These products are intended to be sterile. 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 and its subsidiaries have received reports of three (3) adverse events related to these products. Products were distributed Nationwide to Wholesalers and Retailers starting December 12, 2021.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The products being recalled are available as over the counter (OTC) products used 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.
RECOMMENDATIONS:
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Consumers should stop using the recalled eye drop products and may return any of the recalled products to the place of purchase.
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Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.
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Consumers with questions regarding this recall can contact the company.
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Wholesalers, Distributors and Retailers that have the affected product which is being recalled should cease distribution of the products.
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