FDA Recalls Additional 27 Eye Drop Products Due to Safety Concerns: Key Information to be Aware of

 

FDA Issues Recall for 27 Eye Drop Products Amid Safety Concerns: Important Details to Note

In response to safety concerns, the FDA has initiated a voluntary recall of 27 over-the-counter eye drop products. The affected products pose a risk of causing eye infections, vision loss, and even blindness.

This recall impacts eye drop products sold by prominent retailers such as Amazon, CVS, Rite Aid, and Target. The Food and Drug Administration made the announcement on November 15, prompted by the discovery of unsanitary conditions during investigations.

The manufacturing company responsible for the recalled products is Kilitch Healthcare India Limited, and the recall encompasses all lot numbers and expiration dates of the 27 identified eye drop products.

These products are commonly found under various major retailer banners and brand names, heightening the importance of being informed about this recall.

• CVS Health
• Leader (Cardinal Health)
• Rugby (Cardinal health)
• Rite Aid
• Target Up&Up
• Velocity Pharma
• Walmart

The FDA advisory has led to Amazon discontinuing the sale of a few eye drop products. This voluntary recall marks the most recent development in a series of FDA alerts concerning the safety of specific eye drop products. On October 27, the FDA issued a drug safety alert regarding particular eye drop products that have the potential to induce eye infections, vision loss, and even blindness. Noteworthy products implicated in this safety concern include CVS Health Lubricant Eye Drops, Rite Aid Lubricant Eye Drops, and Target Up&Up Dry Eye Relief Lubricant Eye Drops. An updated list of affected products can be found on the FDA website.

What prompted the FDA to issue a warning regarding eye drops?

On October 25, the FDA issued a directive for the eye drop manufacturer to initiate a comprehensive recall of the implicated products. During an inspection of the manufacturing facilities, FDA investigators uncovered "insanitary conditions" and detected positive bacterial test results in "critical drug production areas."

The presence of contaminants in eye drops poses a significant risk, potentially leading to eye infections and more severe health complications. The FDA emphasized the importance of sterility for these products, stating, "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."

As of now, there have been no reported adverse events, such as eye infections, associated with the affected products. However, details regarding the contamination and its specific cause remain limited. The FDA has not specified the strain of bacteria responsible for the contamination, and additional information is currently unavailable.

Healthline reached out to CVS, one of the retailers affected by the FDA's alert, and received the following response: "Upon receiving notification by the 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 encourages consumers to report any related events through their MedWatch reporting program.

Is it possible for eye drops to lead to a bacterial infection?

The FDA's recent warning is the latest in a series of similar incidents this year, where eye drop products were recalled due to contamination.

In August, the agency cautioned consumers against purchasing and using Dr. Berne's MSM drops, citing the potential for both bacterial and fungal contamination. Dr. Berne's Whole Health Products, the manufacturer, voluntarily recalled the affected eye drops, and no subsequent incidents were reported to the FDA.

In a more alarming incident in February, the CDC investigated a multistate outbreak linked to EzriCare Artificial Tears and two other products from the same manufacturer, resulting in 81 cases of infection of a rare strain of P. aeruginosa across 18 states. Among these cases, 14 patients experienced vision loss, four underwent eyeball removal, and four deaths occurred.

The FDA revealed that the manufacturer, Global Pharma, had numerous violations of manufacturing best practices, including problems with tamper-evident packaging and insufficient levels of preservatives. Global Pharma subsequently initiated a voluntary recall of the implicated 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, emphasized that various types of bacteria have the potential to cause eye infections. He stated, "Myriad types of bacteria, when instilled directly into the eyes, have the biological capacity to cause infection. Frequent culprits like pseudomonas are more tied to what is most likely to contaminate eye drops rather than some inherent capacity in the bacteria."

What are the initial indicators of an eye infection?

At present, the specific bacterial contamination in these eye drops remains uncertain. Nonetheless, individuals who suspect they have used or come into contact with them should be vigilant regarding the symptoms of an eye infection. These symptoms may encompass:

• discharge from the eye
• pain or discomfort
• inflammation
• redness
• increased sensitivity to light
• blurry vision
• feeling like something is in your eye

"As a rule, individuals should seek medical attention, including consulting an optometrist, if they exhibit symptoms of an eye infection, particularly those who regularly use contact lenses. In the presence of any infection, contact lenses should be promptly removed and not worn," advised Adalja.

If you are encountering symptoms indicative of an eye infection and have utilized any of the implicated products, it is advisable to reach out to your healthcare provider and report the incident through the FDA's MedWatch reporting program.

What should you do if you have recalled eye drops?

If you suspect the presence of contaminated products in your household, here are the recommended actions to take:

• Review the complete list of affected products on the FDA's official announcement.
• Dispose of the medications safely and in a sanitary manner. For guidance on proper drug disposal, refer to the FDA's guide to safe drug disposal.
• Contact the retailer from which you purchased the product; you may be eligible for a refund.
• If you have used the product, be attentive to symptoms indicative of an eye infection, as mentioned earlier. Reach out to your healthcare provider promptly if any symptoms arise.
• Report any symptoms or incidents to the FDA through their reporting platform.

The bottom line

The FDA has issued a voluntary recall due to the potential risk of bacterial contamination in 27 over-the-counter eye drop products. The recalled products encompass various brand names, including those from CVS, Rite Aid, and Target. Consumers are advised to be vigilant for symptoms of eye infection if they have utilized any of the listed products and should promptly reach out to their healthcare provider. The FDA strongly recommends individuals who have purchased the affected products to dispose of or discard them immediately.