FDA Caution: Avoid Purchasing and Using Unsanitary Eyedrops

FDA Warns Against Buying Eyedrops Made in ‘Insanitary Conditions’

Introduction

The U.S. Food and Drug Administration (FDA) has issued a warning to consumers regarding the purchase and use of certain eyedrops that have been manufactured in “insanitary conditions.” While no infections or vision loss have been reported thus far, the FDA has discovered the presence of bacteria in critical areas during testing. The list of affected products includes those sold by several major retailers such as Walmart, CVS Health, Leader, Rugby, Rite Aid, Target Up & Up, and Velocity Pharma.

The Call for Removal and Cooperation

The FDA’s warning prompted immediate action from Walmart, which announced that it would be removing the product Equate Hydration PF Lubricant Eye Drop 10 mL from its store shelves and website. CVS, Target, and Rite Aid also responded by pulling the affected eyedrops from their shelves and making them unavailable on their websites. The FDA has urged retailers to remove the products, and consumers are advised to discard any of these products they may have purchased.

Risks and Concerns

The FDA has highlighted the possible risks associated with using these contaminated eyedrops, including the potential for infection and vision loss. However, it is important to note that the FDA has not received any reports of such adverse effects thus far. The FDA issued the warning after discovering contamination within the production area during inspections. The agency recommended that the manufacturer recall all lots on October 25, 2023, due to the insanitary conditions found in the manufacturing facility and positive bacterial test results from environmental sampling within critical drug production areas.

Manufacturer Identification and Response

While the FDA did not disclose the name of the manufacturer or the location of the facility, Cardinal Health and CVS separately stated that Velocity Pharma LLC was the supplier responsible for the Leader and Rugby branded eye drop products. Velocity Pharma, based in Farmingdale, New York, did not respond to inquiries regarding the origin of their eyedrops. Additionally, the FDA did not provide specific information about the location of the facility with unsanitary conditions.

Retailers’ Actions and Consumer Refunds

CVS confirmed that it ceased selling the affected eyedrops as soon as it received the FDA warning. The company has offered customers the option to return the purchased products to CVS Pharmacy for a full refund. Cardinal Health has stated that it is in the process of working with Velocity Pharma and the FDA to initiate a recall of all impacted Rugby Laboratories and Cardinal Health Leader branded eye drop products. As of now, Walmart and Target have not responded to requests for comment.

Past Incidents and Lessons Learned

Earlier this year, the Centers for Disease Control and Prevention (CDC) reported that 81 individuals from 18 states tested positive for Pseudomonas aeruginosa, a bacterium that is resistant to most antibiotics. The CDC and FDA stated that most of these cases were linked to eyedrops that were manufactured in India and sold under the brands EzriCare Artificial Tears, Delsam Pharma Artificial Tears, and Delsam Pharma Artificial Eye Ointment. These products have since been recalled. Disturbingly, 14 out of the 81 individuals experienced blindness, while an additional four individuals required at least one eye to be removed. Tragically, four people ultimately lost their lives as a result of these infections.

The Importance of Eye Health and Hygiene

These recent incidents underscore the importance of maintaining proper eye health and hygiene. Ensuring the safety of products used on or near the eyes is paramount, as any compromise in manufacturing and quality control can lead to severe consequences. Consumers are reminded to be vigilant in checking for FDA-approved and regulated products, especially when it comes to sensitive areas like the eyes. It is crucial to prioritize eye care and seek medical attention if any adverse reactions or symptoms occur after using eyedrops.

Conclusion

The FDA’s warning about buying and using eyedrops manufactured in “insanitary conditions” serves as a reminder of the vital role that regulatory bodies play in safeguarding public health. The collaboration between the FDA and retailers to remove these products from shelves and offer refunds demonstrates a commitment to consumer safety. Consumers should prioritize eye health by exercising caution, selecting FDA-approved products, and promptly reporting any adverse effects to healthcare professionals. Ultimately, the goal should be to prevent such incidents and ensure the availability of safe and effective eye care products for all.