In January of 2023, a multistate outbreak of carbapenem-resistant Pseudomonas aeruginosa (CRPA) was reported in connection with the use of EzriCare® Artificial Tears eye drops. A month later, the U.S. Food & Drug Administration announced a nationwide recall of both EzriCare® and Delsam Pharma Artificial Tears eye drops due to “potential microbial contamination.” And just a week later, the first consumer class action lawsuit regarding the contaminated Ezricare® Artificial Tears eye drops was filed in federal court.
The product liability attorneys at Shelsby & Leoni understand how devastating it can be to suffer harm due to medical treatment or products. If you or a loved one have contracted a bacterial infection associated with the use of EzriCare® Artificial Tears eye drops, we are here to provide you with the legal guidance and representation you need.
What are Ezricare® Artificial Tears?
EzriCare® Artificial Tears is a lubricating eye drop solution intended to soothe dry and irritated eyes. The product comes in the form of an eye dropper containing a preservative-free solution composed of 1% Carboxymethylcellulose Sodium.
FDA Recalls Ezricare®, Delsam Pharma, Pharmedica, and Apotex Corp. Eye Drops
On February 2, 2023, the U.S. Food & Drug Administration announced a nationwide recall of both Ezricare® & Delsam Pharma Artificial Tears eye drops due to potential microbial contamination. The recall was prompted by 55 reports of adverse events, including eye infections, permanent loss of vision, and death from a bloodstream infection.
In early March 2023, the FDA issued additional recalls for Pharmedica’s Purely Soothing 15% MSM Drops and Apotex Corp. Brimonidine Tartrate Ophthalmic Solution, 0.15% eye drops for potential lack of sterility.
Which Eye Drop Products Have Been Recalled?
The specific eye drops products being recalled are:
Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottles.
Ezricare® NDC 79503-0101-15, UPC 3 79503 10115 7
Delsam Pharma’s NDC 72570-121-15, UPC -72570-0121-15
Delsam Pharma’s Artificial Eye Ointment NDC 72570-122-35, UPC 3 72570 12235 3
Purely Soothing 15% MSM Drops LOT# 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9
All listed Brimonidine Tartrate Ophthalmic Solutions have a strength of 0.15%.
For the 5mL pack size, the NDC number is 60505-0564-1, and the UPC code on the carton is 360505056415. The UPC code on the bottle is (01)0(03)60505056415. The lot numbers for this pack size are TJ9848, TJ9849, TK0258, and TK5341. The expiry date for lot numbers TJ9848 and TJ9849 is 02/2024, while the expiry date for lot numbers TK0258 and TK5341 is 04/2024.
For the 10mL pack size, the NDC number is 60505-0564-2, and the UPC code on the carton is 360505056422. The UPC code on the bottle is (01)0(03)60505056422. The lot number for this pack size is TK0261, and the expiry date is 04/2024.
For the 15mL pack size, the NDC number is 60505-0564-3, and the UPC code on the carton is 360505056439. The UPC code on the bottle is (01)0((03)60505056439. The lot number for this pack size is TK0262, and the expiry date is 04/2024.
The Ezricare® and Delsam Pharma eye drop lots were manufactured in India by Global Pharma Healthcare, located in Tamilnadu, India. Global Pharma produces a variety of over-the-counter healthcare products in addition to eye drops and imports many of these products into the United States under the name Aru Pharma Inc.
The FDA has determined that the recall was necessary based on manufacturing problems, including a lack of testing and proper controls on the packaging. In response, the FDA has also blocked the importation of these contaminated eye drops into the United States.
Pharmedica USA LLC manufactures Purely Soothing 15% MSM Drops in Phoenix, Arizona. They are distributed worldwide via Trade shows and online e-commerce shops like Amazon Marketplace.
Apotex Corp. Brimonidine Tartrate Ophthalmic Solution, 0.15% prescription eye drops are manufactured in Canada and distributed through Wholesalers, Distributors, Warehousing Chains, Mail Order Pharmacy, and Long-Term Care Pharmacy. Purely Soothing Drops and Apotex Corp. eye drops were recalled due to cracked bottle caps and non-sterility.
How Did the Ezricare® and Delsam Eye Drops Become Contaminated?
The cause of the contamination in Ezricare® Artificial Tears eye drops is yet to be entirely determined. The CDC conducted laboratory testing on a variety of opened Ezricare® and Delsam bottles, some from those who reported a pseudomonas aeruginosa infection and others from unaffected consumers.
The examination confirmed the presence of Pseudomonas aeruginosa bacteria in the eye drops, and a deeper analysis of the bacteria strain revealed that it matched the strain found in individuals suffering from the outbreak. This solidified the connection between the eye drops and the infections.
All eye drop products, including the Ezricare® Artificial Tears, lack preservatives. This means the bacterial contamination must have occurred during the production process, possibly through contamination on the assembly line or at the manufacturing facility.
What Are the Pathogens Involved in the Ezricare® Artificial Tears Infections?
The Centers for Disease Control and Prevention (CDC) has identified two primary pathogens involved in these infections: Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES) producing Carbapenem-resistant Pseudomonas Aeruginosa (CRPA). This strain is commonly referred to as VIM-GES-CRPA and is antibiotic resistant, making it very difficult to treat.
What is Pseudomonas Aeruginosa?
Pseudomonas aeruginosa, also known as P. aeruginosa, is a common bacterium found in environments around the world. It is commonly found in hospitals and other medical facilities, where it infects patients through medical devices like ventilators, as well as through touch and standing bodies of water. This bacterium is a leading cause of hospital infections, with common sites of infection including burns, airways, urinary tracts, and wounds.
Pseudomonas Aeruginosa is Antibiotic Resistant
One of the biggest concerns with P. aeruginosa is its resistance to most drugs, which makes treatment difficult. This bacterium has the ability to mutate and effectively resist antibiotics, putting patients with already compromised health in a very precarious situation.
VIM-GES-CRPA is a particularly dangerous strain of P. aeruginosa, as it has demonstrated a resistance to antibiotics from the carbapenem family, as well as other antibiotics.
Ezricare® Artificial Tears and the Risk of VIM-GES-CRPA Eye Infections
The eyes are delicate and sensitive organs, which makes it critical to take measures to properly sterilize all medical products and equipment that come into contact with them. Regrettably, the recent situation involving Ezricare® eye drops has resulted in a dangerous pathogen reaching the eyes and causing infections.
Bacterial infections of the eye are a serious concern as they can put someone’s vision at risk. They often start in the cornea, the clear front surface of the eye, and can quickly spread and pose a threat to the delicate structures of the eye. The fact that P. aeruginosa is highly resistant to drugs makes the possibility of permanent eye damage a real danger.
Potential Eye Infection Conditions Associated with CRPA
Carbapenem-resistant Pseudomonas aeruginosa (CRPA) infections of the eye can lead to conditions such as:
Endophthalmitis: an ocular infection that penetrates the eye and can cause blindness
Keratitis: an infection of the cornea
Conjunctivitis: also known as pink eye, this is an infection of the conjunctiva
Cellulitis: an infection of the skin surrounding the eye, such as the eyelid
Dacryocystitis: an infection affecting the tear glands and ducts
Additionally, the bacterial infection can become systemic and lead to secondary medical issues that require hospitalization such as:
Respiratory infection
Urinary tract infection
Sepsis
For young patients, or those with weakened immune systems or auto-immune diseases, these infections could lead to death.
Signs of Pseudomonas Aeruginosa Eye Infections may include:
Red eyes
Eye pain
Eye discharge
Watery eyes
Dry eyes
Light sensitivity
Swollen eyes
Swelling around the eyes
Itching
Blurry vision
If you believe that you or someone you know has been affected by contaminated eye drops, contact a healthcare provider and seek medical attention immediately. They will be able to test any products you have as well as yourself to determine if an infection is present.
Ezricare® Eye Drops Lawsuit? Hire a Medical Lawyer With Experience Winning Product Liability Cases
If you or a loved one suffered from a VIM-GES-CRPA infection caused by contaminated Ezricare® eye drops, you need a lawyer handling your claim who has a proven track record in medically-related product liability cases.
Our attorneys have won many 6 & 7 figure product liability claims for cases related to medical products, pharmaceuticals, and OTC drugs. They have the knowledge, experience, and resources to build a strong case for you. His team’s deep understanding of the medical industry and expertise in legal strategies and techniques will give you an advantage in the courtroom.
As skilled medical malpractice lawyer, who were previously insurance defense attorneys they know the complexities of the medical issues involved and how those issues can impact your life. Their team will be able to analyze medical records, consult with experts, and understand the actual life-long impacts of the injuries suffered.
Moreover, the mass tort attorneys at Shelsby & Leoni understand how to assign a dollar amount to your damages, ensuring you receive the compensation you deserve. Contact Shelsby & Leoni today to schedule a free consultation.
Frequently Asked Questions
Where Were the Recalled Eye Drops Sold?
It’s currently believed that the contaminated Ezricare® and Delsam eye drops were only sold through Wal-Mart and online retailers Amazon and Ebay.
What States Have Reported Infections From Ezricare® Eye Drops?
So far the infections have been reported in 12 states including Texas, California, Florida, and New Jersey. Given that the eye drops were sold nationwide, cases will likely be present in all 50 states.
Who Can File an Ezricare® Artificial Tears Lawsuit?
If you or someone you love has used Ezricare® Artificial Tears and suffered from permanent vision loss, eye infections, or other injuries, you may be eligible to file a lawsuit. To determine your eligibility and to protect your rights, contact the Hastings Law Firm today for a free case review.
How Much Does it Cost to File an Ezricare® Lawsuit?
It won’t cost you anything upfront or out of pocket to file an Ezricare® eye drops lawsuit. The Hastings Law Firm handles cases on a contingency basis, meaning we only get paid if you are awarded compensation.
How Long Will a Lawsuit Take and When Will I Receive Compensation?
The timeline for recovering damages depends greatly on your level of damages, venue, and whether your case is settled out of court or goes to trial. We understand that you may be experiencing hardship and suffering, and we are here to support and guide you through the process. Our experienced attorneys will work diligently to pursue the compensation and justice you deserve, keeping you informed every step of the way.
Where Will My Eye Drops Lawsuit Be Filed?
Deciding on the appropriate jurisdiction for your Ezricare® lawsuit is not always a straightforward process and there are several factors that can influence proper venue. Your lawsuit may be filed in one of the following places: where you reside, where you purchased the eye drops, or where the manufacturer is headquartered. It is worth noting that EzriCare’s base of operations is in Lakewood, New Jersey. While this information is relevant to the jurisdictional determination, it is not the only determining factor.
How Much Compensation Can I Expect to Receive for My Ezricare® Eye Drop Lawsuit?
Since these cases have just been filed with no known settlements, there’s no reliable estimation of case value at this time. Key considerations that will determine your damages include the extent and monetary consequences of any harm you’ve suffered, as well as the legal venue where the case is filed.