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FDA Warns Consumers Not to Purchase CVS Eye Drops Due to Risk of Eye Infection
On October 27, 2023, the FDA issued the Alert [1.] regarding the following CVS eye drop products:
|
Retailer/ Label |
Product | Product Information |
|---|---|---|
| CVS Health | Lubricant Eye Drops 15 ml (single pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% w/v |
| Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% w/v | |
| Lubricant Gel Drops 15 ml (single pack) | Carboxymethylcellulose Sodium Eye Drops 1% w/v | |
| Lubricant Gel Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium Eye Drops 1% w/v | |
| Multi-Action Relief Drops 15 ml | Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops | |
| Lubricating Gel drops 10 ml | Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops | |
| Lubricant Eye Drops 10 ml (single pack) | Propylene Glycol Eye Drops 0.6% w/v | |
| Lubricant Eye Drops 10 ml (twin pack) | Propylene Glycol Eye Drops 0.6% w/v | |
| Mild Moderate Lubricating Eye Drops 15 ml (single pack) | Polyethylene Glycol 400 Eye Drop '0.25% w/v |
FDA issued the warning after investigators found bacterial contamination in drug production areas of a manufacturing facility. The agency is recommending that CVS issue an immediate recall for its eye drops. CVS has stated that it is removing the products in-store and online.
What You Need to Know About the 2023 Eye Drops Recall
The FDA's Oct. 2023 alert is the most recent in a series of warnings against using potentially contaminated eye drop products. In August, the FDA urged consumers to stop using LightEyez MSM Eye Drops Eye Repair product, and Dr. Berne's MSM Drops 5% Solution over potential bacterial and fungal contamination.
In February, the U.S. Centers for Disease Control and Prevention (CDC) reported an outbreak of Pseudomonas aeruginosa linked to more than 10 different brands of eye drops, the most common being Ezri Care Artificial Tears. The bacteria strain was found in 81 people, 4 of whom had died from infections, according to the CDC.
It was subsequently determined that microbial testing by India-based Global Pharma Healthcare of its eye product was inadequate and that the manufacturer failed to use adequate, tamper-resistant packaging and distributed the drugs without proper preservatives.
Eye Infection Symptoms
Common symptoms of an eye infection from contaminated eye drops may include:
- Blurry vision
- Discharge
- Pain or discomfort
- Redness of the eyelid or eye
- Feeling like there is something in the eye
- Increased sensitivity to light
If you have any of these symptoms, please see an eye care professional immediately.
FDA Warns to Stop Using 26 Types of OTC Eye Drops: ABC News Video
Class Action Alleges CVS Pink Eye Drops Misbranded, Require FDA Approval
In September 2023, CVS was hit with a class action lawsuit after the company received an FDA warning letter about its over-the-counter CVS Health Pink Eye Relief Drops, which the agency said are labeled in a manner that requires regulatory approval.
Specifically, the lawsuit contends that certain efficacy claims on the packaging of CVS’ Pink Eye Drops lead consumers to believe that the product is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body,” according to the lawsuit.
As a result, the FDA warned CVS that its Pink Eye Drops are essentially an unapproved new drug not generally recognized as safe and effective for its promoted uses or evaluated by qualified experts.
Furthermore, the complaint challenges the label claims that the Pink Eye Drops have “a homeopathic formula that stimulates the body’s ability to relieve redness, burning, watery discharge, and sensations of grittiness.” The eye drops are misbranded given that they are unable to “relieve the identified symptoms,” according to the class action.
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