It’s hard not to be aware of the extensive recall of artificial tears that have occurred over the past year due to potential contamination from dangerous bacteria.
Since multiple reports of severe ocular and systemic infections were released by the Centers for Disease Control and Prevention (CDC) in early January 2023, the US Food and Drug Administration (FDA) has been heavily investigating multiple healthcare pharmaceutical companies throughout the year, resulting in recalls of over 30 artificial tears by the end of 2023.
What does this mean for eyecare practitioners and the eyecare field? This article will review the timeline of the artificial tears recalls, discuss the underlying reasons for the recalls, and how these events will affect the eyecare industry in the future.
FDA classification of recalls
When recalls circulate to the general public, they typically concern food products. In some instances, they can include pharmaceutical products.
Recalls can occur in one of two ways:
- The FDA demands a manufacturer recall.
- Companies issue a voluntary recall after a warning from the FDA.
In regards to the artificial tears recall, EzriCare/Delsam Pharma was forced into a manufacturer recall due to known contamination of their products, resulting in serious adverse events.
On the other hand, Kilitch Healthcare, who supplies companies such as CVS Health, Cardinal Health [Leader and Rugby], Rite Aid, Target Up & Up, Velocity Pharma, and Walmart, voluntarily recalled their products after a strong warning from the FDA.
Download the List of Recalled Eye Drops here!
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List of Recalled Eye Drops
Use this list of recalled eye drops for quick reference when discussing artificial tear options with patients.
FDA recall protocols
There are numerous ways in which the FDA can discover hazardous products, including:
- The manufacturer discovers a defect and contacts the FDA.
- The FDA receives a report of a health problem stemming from particular products.
- The CDC notices a trending health problem related to an FDA-regulated product (as seen in this case).
- FDA employees inspect the manufacturer’s factory and determine the likelihood that a problem will arise.1
Technically, a recall is defined as an action executed by a manufacturer at any time to remove a defective or harmful drug product from the market when the drug is discovered to be in violation of laws and regulations administered by the FDA.2 However, recalls may be requested by the FDA or legally mandated by the FDA.3
Interestingly, approximately 80% of medications that Americans consume are manufactured abroad, such as in China and India. These can help to keep manufacturing process costs down but can lead to subpar standards and sanitary conditions.4
The next steps in FDA recalls
After the FDA classifies a recall (see the list below in blue), they work with the manufacturer to develop a recall strategy. Once it is determined that the company’s corrective actions are appropriate and sufficient, the FDA makes sure the product is destroyed or suitably reconditioned and also follows up on why it was defective in the first place.2
The FDA will only alert the media in cases where there is potential serious harm from a product and issue a public warning listing the product, brand name, and reason for recall.1
The recall is terminated when the FDA determines that sufficient efforts have been made to remove or correct the product in accordance with the recall strategy. Proper removal or correction of the product correlates with the degree of hazard of the recalled product.3
Recall classifications
The FDA’s recall classification system is based on the product’s potential injury or harm to a person. The recall of artificial tears falls under Class I due to reported blindness and death.1
- Class I: Recalls for products that could cause severe injury or death.
- Class II: Recalls for products that might cause significant injury or temporary illness.
- Class III: Recalls for products that are unlikely to cause injury or illness but violate FDA regulations.
Timeline of artificial tear recalls
May 2022
As early as May 2022, patients and healthcare facilities began reporting an increase in drug-resistant ocular infections to the CDC over multiple states.5 After many months of gathering data from patients and doctors, the FDA and CDC were able to find a common link between all reports—an artificial tear drop produced by EzriCare/Global Pharma.
January 2023
In late January 2023, the CDC made an official report of nearly 55 patients across 12 states with ocular and systemic infections by drug-resistant Pseudomonas aeruginosa linked to EzriCare Artificial Tears. Reports included permanent vision loss from eye infections, hospitalizations for lung infections, and even one death by bloodstream infection.6
February 2023
Not far behind the CDC report, the FDA alerted the public to immediately cease the use of EzriCare and Delsam Pharma Artificial Tears (under Global Health Pharma) due to potential bacterial contamination.
After an 11-day inspection of Global Pharma facilities in India, the FDA reported multiple violations of the Current Good Manufacturing Practice (CGMP), including lack of appropriate microbial testing, formulation issues, and lack of proper controls concerning tamper-evidence packaging.7
Definition of the Current Good Manufacturing Practice:8
The CGMP provides regulations for drugs and contains minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packaging of a drug product. These regulations ensure that the product is safe for use and has the ingredients and strength it claims to have.
May 2023
By mid-2023, the CDC had reported up to four deaths, 14 cases of vision loss, and even four eye enucleations across 18 states. These were all due to a rare strain of drug-resistant Pseudomonas aeruginosa found in the EzriCare eye drop solution.6
October 2023
By October 2023, nearly 27 over-the-counter eye drops across nine retailers had been reported by the FDA for potential sterility issues.
Although severe adverse events were only reported with EzriCare/Delsman Pharma drops, Kilitch Healthcare India—who manufactures eye drops for many of the large retailers including CVS, Target, Walmart, Rugby, Leader, Velocity, and Rite Aid decided to voluntarily recall all their eye drops after the FDA discovered unsanitary conditions.9
November 2023
Amazon removed seven eye-drop products from its e-commerce site after the FDA warned the company that the products were unapproved. This brought the total number of eye drops recalled to approximately 45!10
Check out the List of Recalled Eye Drops!
The impact of eye drop recalls on the eyecare industry
It is no surprise that this recall will have a huge impact on the eyecare industry. The FDA is asking Congress for new powers, including the ability to mandate drug recalls and require eye drop makers to undergo inspections before shipping products to the US.11
Large retail manufacturers such as Kilitch Healthcare will likely need to meet stringent standards set by the FDA before their items are allowed back on the shelf. Hopefully, these recalls will have a ripple effect on other healthcare-related products and businesses, resulting in safer over-the-counter products available to consumers.
The effect on eyecare and healthcare providers
Approximately 20 million people in the United States (344 million people worldwide) have dry eye disease (DED), and that number is growing in both young and old adults.12 Furthermore, based on the Eyes On Eyecare 2023 Dry Eye Report, the majority of eyecare professionals (46.5%) still consider artificial tears as a first-line therapy for dry eye disease.13
Therefore, artificial tears still play an enormous role in treating our patients. However, what this recall has reiterated is that all drops are not created equal, and it is up to us as ECPs to educate our patients on the importance of using safe, brand-name artificial tears.
Precautions ECPs and healthcare providers can take to keep patients safe
Although preservative-free artificial tears are often recommended over preservative tears, it is important to remind patients that once preservative-free artificial tears are opened, they MUST be thrown out after 24 hours due to the risk of bacterial contamination.14
Taking it even one step further, eyecare professionals (ECPs) can stock artificial tears that are only available for purchase in doctor’s offices, such as Oasis Tears. This will ensure the patient is only using eye drops that are safe for their eyes.
The CDC has also listed multiple recommendations (see below) for ECPs/healthcare professionals in the midst of this recall. Eyecare practitioners may consider elevated caution when managing ocular infections and strongly consider cultures/anti-microbial testing when conditions are not improving with treatment.
Recommendations for healthcare practitioners by the CDC include:15
- Immediately discontinue the use of EzriCare and Deslam products.
- Advising patients who have used these products to monitor for signs and symptoms of ocular or systemic infection.
- Perform cultures and antimicrobial testing when clinically indicated.
- Ask patients currently being treated for keratitis or endophthalmitis if they have used any of the recalled products.
- When treating drug-resistant infections, consult with a specialist knowledgeable in the treatment of antibiotic-resistant bacteria to determine the best treatment.
Conclusion
This was an important lesson for practitioners and patients that all artificial tears are not created equal.
Patients will likely turn to their eye doctors for guidance on which tears are safe to use, and eye doctors should be ready to stress the importance of proper use and storage of FDA-approved tears.
