FDA Recalls Eye Drops That Caused Vision Loss and One Death

The FDA took precautions and called for a recall of the eye drops after the eye drop brands failed to comply with the company's current good manufacturing practice (CGMP), citing multiple violations, including the lack of appropriate microbial testing and formulation issues, which is when the company manufactures and distributes ophthalmic drugs in multi-use bottles without an adequate preservative. 

Currently, on top of the recalls, the FDA has placed on one of the brands, Global Pharma Healthcare Private Limited, the owners of EzriCare, on an import alert for providing an inadequate response to a records request along with the company's non-compliance with the CGMP requirements. The import alert will prevent Global Pharma Healthcare Private Limited products from entering the United States. 

Pseudomonas aeruginosa is a form of bacteria that is most commonly found in the environment, like in soil and water. It is a common cause of healthcare-associated infections, which include, but are not limited to, the following:

• bloodstream infections
• pneumonia
• surgical site infections
• urinary tract infections

Pseudomonas can be a serious problem in hospitals and other healthcare facilities, where outbreaks of this highly antibiotic-resistant "superbug" have become increasingly common over the years. For example, in 2017, multidrug-resistant Pseudomonas aeruginosa was responsible for causing an estimated 32,600 infections among hospital patients and caused roughly 2,700 deaths in the U.S., according to the CDC.

As of January 31, 2023, the CDC has identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to the use of the Delsam Pharma and EzriCare Artificial Tears. Those states currently include California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Wisconsin, and Washington. Associated adverse events include:

• Hospitalization
• One death from bloodstream infection
• Permanent vision loss from eye infections

According to the CDC, individuals who have used the eye drops should immediately seek medical care if they have the following symptoms:

• Blurry vision
• Eye pain or discomfort
• The feeling of something in your eye or foreign body sensation
• Increased sensitivity to light
• Redness of the eye or eyelid
• Yellow/green or clear discharge from the eye

If you or a loved one have used EzriCare Artificial Tears, Delsam Pharma's Artificial Tears, Purely Soothing 15% MSM Drops, or  Brimonidine Tartrate Ophthalmic Solution. 0.15% and are showing signs or symptoms of an eye infection, don't wait. Talk to your healthcare provider or seek medical care immediately.

As instructed by the CDC, you should immediately stop all use of the named eye drops above. For your convenience, below, we have listed those specific teardrops that have been recalled.

• Delsam Pharma: NDC 72570-121-15, UPC -72570-0121-15
• Ezricare: NDC 79503-0101-15, UPC 3 79503 10115 7
• Purely Soothing 15% MSM Drops (1 oz): UPC 7-31034-91379-9,
• Purely Soothing 15% MSM Drops (1/2 oz): UPC 7-31034-91382-9
• Brimonidine Tartrate Ophthalmic Solution. 0.15% (5 mL): NDC 60505-0564-1, UPC (01)0(03)60505056415
• Brimonidine Tartrate Ophthalmic Solution. 0.15% (10 mL): NDC 60505-0564-2, UPC (01)0(03)60505056422
• Brimonidine Tartrate Ophthalmic Solution. 0.15% (15 mL): NDC 60505-0564-3, UPC (01)0(03)60505056439

If you or someone you know has used or is in possession of one of the contaminated eye products mentioned, contact your medical care provider for help, and then contact a Morgan & Morgan attorney. When you hire one of our attorneys, they will work with you 24/7. Your attorney and team will work with medical professionals and other experts to gather evidence to ensure that you have the strongest case possible. There is no charge for a consultation with us, and if we don't win your case, you will not owe us any money for our services.

For more information on how a Morgan & Morgan attorney can help you, please complete our free, no-obligation case evaluation form today.