Medicine recalls
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| The United States: FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection |
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The US Food and Drug Administration (FDA) is warning consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness. Patients 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. The products are marketed under the following brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up and Velocity Pharma.
The affected products are:
- CVS Health Lubricant Eye Drops 15 ml (single pack)
- CVS Health Lubricant Eye Drops 15 ml (twin pack)
- CVS Health Lubricant Gel Drops 15 ml (single pack)
- CVS Health Lubricant Gel Drops 15 ml (twin pack)
- CVS Health Multi-Action Relief Drops 15 ml
- CVS Health Lubricating Gel drops 10 ml
- CVS Health Lubricant Eye Drops 10 ml (single pack)
- CVS Health Lubricant Eye Drops 10 ml (twin pack)
- CVS Health Mild Moderate Lubricating Eye Drops 15 ml (single pack)
- Rugby (Cardinal Health) Lubricating Tears Eye Drops 15 ml
- Rugby (Cardinal Health) Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml
- Leader (Cardinal Health) Dry Eye Relief 10 ml
- Leader (Cardinal Health) Lubricant Eye Drops 15 ml (single pack)
- Leader (Cardinal Health) Lubricant Eye Drops 15 ml (twin pack)
- Leader (Cardinal Health) Dry Eye Relief 15 ml
- Leader (Cardinal Health) Eye Irritation Relief 15 ml
- Rite Aid Lubricant Eye Drops 15 ml (twin pack)
- Rite Aid Lubricant Eye Drops 10 ml (twin pack)
- Rite Aid Gentle Lubricant Gel Eye Drops 15 ml
- Rite Aid Lubricant Gel Drops 15 ml
- Rite Aid Lubricating Gel Drops 10 ml
- Rite Aid Multi-Action Relief Drops 15 ml
- Target Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml
- Target Up&Up Extreme Relief Dry Eye 15 ml (single pack)
- Target Up&Up Extreme Relief Dry Eye 30 ml (twin pack)
- Velocity Pharma LLC Lubricant Eye Drop 10 ml (triple pack)
These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.
FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. FDA also recommends consumers properly discard these products.
CVS, Rite Aid and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online and should not be purchased.
FDA has not received any adverse event reports of eye infection associated with these products at this time. FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program.
Please refer to the following website in FDA for details:http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Saturday, Oct 28, 2023
Issued at HKT 13:00
FDA is updating the list of over-the-counter eye drop products consumers should not purchase or use to include Equate Hydration PF Lubricant Eye Drop 10 ml sold by Walmart in stores and online. Walmart is removing the product from their store shelves and website. In Hong Kong, the above product is not a registered pharmaceutical product.
Content last updated: Thursday, Nov 2, 2023
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