- The FDA has announced a voluntary recall for 27 over-the-counter eye drop products.
- The contaminated products could lead to eye infections, loss of vision, and blindness.
- Several major retailers’ products have been impacted, including Amazon, CVS, Rite Aid, and Target.
The Food and Drug Administration (FDA)
A total of 27 eye drop products are included in the voluntary recall by manufacturing company Kilitch Healthcare India Limited. The recalled eye drop products include all lot numbers and expiration dates.
The products are marketed under the banners of major retailers and brand names including:
- CVS Health
- Leader (Cardinal Health)
- Rugby (Cardinal health)
- Rite Aid
- Target Up&Up
- Velocity Pharma
The FDA warning also prompted Amazon to stop selling a handful of eye drop products.
The voluntary recall is the latest in a series of FDA warnings about the safety of certain eye drop products.
On October 27, the FDA issued a
Specific products include CVS Health Lubricant Eye Drops, Rite Aid Lubricant Eye Drops, and Target Up&Up Dry Eye Relief Lubricant Eye Drops. A current list of the affected products is available
On October 25, the FDA urged the eye drop manufacturer to perform a total recall of the affected products.
During an inspection of manufacturing facilities, the agency’s investigators uncovered “insanitary conditions” and positive bacterial test results in “critical drug production areas.”
Contaminated eye drops can easily lead to eye infections and more serious health outcomes.
“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,” said the FDA in their announcement.
So far, there have been no reported adverse events, such as eye infections, associated with the affected products. However, details about the contamination and its cause are still sparse. No strain of bacteria has been specified in the contamination. A representative for the FDA told Healthline that they didn’t have any additional information to share at this time.
Healthline contacted CVS, one of the retailers whose products were affected by the FDA’s alert, and was sent the following response:
“Upon receiving notification by FDA, we’ve immediately stopped the sale in-store and online of all products supplied by Velocity Pharma within the CVS Health Brand Eye Products portfolio. Customers who purchased these products can return them to CVS Pharmacy for a full refund. We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers, and are fully cooperating with the FDA on this matter.”
The FDA is encouraging consumers to report any such events through their
The FDA’s warning follows two other similar incidents this year, during which eye drop products were recalled due to contamination.
Even more concerning, in February the CDC investigated
Global Pharma has since voluntarily recalled the products.
Dr. Amesh Adalja, a Senior Scholar at the Johns Hopkins Center for Health Security, and an Adjunct Assistant Professor at the Johns Hopkins Bloomberg School of Public Health, said many types of bacteria can cause eye infections.
“Myriad types of bacteria, when instilled directly into the eyes, have the biological capacity to cause infection,” Adalja said. “Frequent culprits like pseudomonas are more tied to what is most likely to contaminate eye drops rather than some inherent capacity in the bacteria.”
It is unclear at this time what kind of bacterial contamination is potentially present in these eye drops. However, consumers who believe they may have used or been in contact with them should be aware of the symptoms of eye infection, which can include:
- discharge from the eye
- pain or discomfort
- increased sensitivity to light
- blurry vision
- feeling like something is in your eye
“In general, patients should seek medical (which includes optometrist) attention if they have symptoms of an eye infection, especially if they regularly wear contact lenses — which should be removed and not worn in the presence of any infection,” Adalja said.
If you are experiencing symptoms of an eye infection and have used any of the affected products, you should contact your healthcare provider, and the
If you think you might have contaminated products in your household, here’s what to do:
- Check the FDA’s
full list of affected productsin their announcement.
- Discard or dispose of the medications in a safe and sanitary manner. If you need additional guidance, check out the
FDA’s guide to safe drug disposal.
- You may be entitled to a refund, so contact the retailer where you bought the product.
- If you’ve used the product, be mindful of any symptoms associated with eye infection like those listed above, and contact your healthcare provider.
- You can also
report any symptomsor events to the FDA.
The FDA announced a voluntary recall about the risk of bacterial contamination in 27 over-the-counter eye drop products.
The affected products included in the recall include brand names from CVS, Rite Aid, and Target, among others.
Consumers should be aware of the symptoms of eye infection if they’ve used any of the listed products and immediately contact their healthcare provider.
The FDA is urging anyone who has purchased the products to immediatly discard or dispose of them.
Source link : https://www.healthline.com/health-news/fda-eye-drop-recall-2023
Publish date : 2023-11-18 10:15:39
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