The FDA Has Issued Another Warning About Eye Drops
Update (February 3, 2024): It looks like we're starting off the year right where we left off, when it comes to eye drop recalls. This time, it's a warning, not an official product recall, being put out by The Food and Drug Administration (FDA) — but it's still just as important to pay attention and heed the advice.
The FDA is warning consumers not to purchase or use South Moon, Rebright or FivFivGo eye drops because of the potential risk of eye infection. "These are copycat eye drop products that consumers can easily mistake for Bausch + Lomb’s Lumify brand eye drops," according to the FDA alert.
South Moon, Rebright and FivFivGo eye drops are sold online, and claim to treat eye conditions such as glaucoma — but they are unapproved drugs and should not even be available for sale in the U.S., says the FDA.
Test samples of South Moon drops were shown to be contaminated with a type of bacteria that's resistant to antibiotics. Rebright test samples were negative for contamination and test samples of FivFivGo weren't able to be obtained; however, the FDA is still urging consumers not to buy eye drops from all three brands and to stop using and throw out any of the affected brands.
No adverse events reported related to South Moon, Rebright and FivFivGo eye drops had been reported as of this writing, but the FDA "has received reports related to possibly fake Lumify, including product quality concerns, eye irritation, pain and infection." See your doctor immediately if you notice signs of eye infection, such as pain or discomfort; blurry vision; yellow or green discharge; and redness.
The FDA recommends consumers only purchase eye drops from reputable retailers and to "beware of online retailers."
Original: After months of eye drop recalls, there’s more. The FDA is warning consumers to immediately stop using and dispose of 27 eye drop products after another mass recall, this time by the manufacturer Kilitch Healthcare India Limited.
“It is pertinent to be mindful of the over-the-counter eye drop recalls. Consult the FDA list of affected drops, or ask your eye care practitioner if your drops are safe to use if you’re unsure,” urges Melissa Barnett, OD, director of optometry at UC Davis in California. “An increased risk of infection and potentially vision loss may occur if contaminated drops are used.”
The company issued a voluntary recall after FDA investigators found unsanitary conditions, which poses a potential risk of eye infections or other eye-related issues. Previous eye drop products that were slapped with recalls in March, May, August and October of this year were due to either bacterial contamination or unsanitary conditions; they were sold at popular retailers such as CVS, Target, Rite Aid and Walmart, as well as online. The first batch of recalled eye drops from March caused eye infections in dozens of eye drop users and several cases of blindness; a handful of individuals required eyeball removal surgery and there were at least four associated deaths.
Eye drops are intended to be sterile, especially due to a heightened risk for infection since they bypass some of the body's natural defenses by being applied directly into the eyes. As of this writing, Kilitch Healthcare India Limited “has not received any reports of adverse events related to this recall,” according to a news release posted by the FDA.
Signs of an eye infection include:
Yellow, green or clear discharge from the eye
Eye pain or discomfort
Redness of the eye or eyelid
Feeling of something in your eye (foreign body sensation)
Increased sensitivity to light
Blurry vision
Eyes sticking shut when you wake up
Contact your doctor or another medical professional immediately is you experience these common signs of an eye infection. If you wear contact lenses: “Take the contacts out and bring them to an eye doctor’s office, as they may want to send them out for a culture to assess if certain organisms are growing, which could help tailor treatment,” recommends Brian Boxer Wachler, MD, ophthalmologist and medical reviewer at All About Vision.
You or your doctor can also report adverse events or quality issues to the FDA’s MedWatch Adverse Event Reporting program.
If you have any of the recalled products in your medicine cabinet (scroll down for a full list of eye drop products recalled this year), the FDA is recommending that you discard them immediately per their recommendations for safe disposal of unused or expired medicine; this usually entails either dropping the affected products off at a local safe disposal or drug take back site, or following any disposal instructions that may be included in the product’s instruction packet.
Here's a full list of eye drops recalled in 2023:
EzriCare Artificial Tears Lubricant Eye Drops, NDC 79503-0101-15 and UPC 3 79503 10115 7.
Delsam Pharma Artificial Tears Lubricant Eye Drops, NDC 72570-121-15 and UPC 3 72570 12115 8.
Delsam Pharma Artificial Eye Ointment, NDC 72570-122-35 and UPC code 3 72570 12235 3.
Clear Eyes Once Daily, Eye Allergy Itch Relief: Lot 114349, Lot 117396, Lot 0120128, Lot 114371, and Lot 123781.
Purely Soothing 15% MSM Drops, LOT#: 2203PS01, UPC 7 31034 91379 9; and LOT#: 1808051, UPC 7 31034 91382 9.
Brimonidine Tartrate Ophthalmic Solution, 0.15%, NDC numbers 60505-0564-1, 60505-0564-2 and 60505-0564-3.
Dr. Berne’s MSM Drops 5% Solution, Lot# 6786.
LightEyez MSM Eye Drops-Eye Repair, NDC number not provided.
CVS Health Lubricant Eye Drops 15 ml (single pack), NDC number 76168-702-15.
CVS Health Lubricant Eye Drops 15 ml (twin pack), NDC number 76168-702-30.
CVS Health Lubricant Gel Drops 15 ml (single pack), NDC number 76168-704-15.
CVS Health Lubricant Gel Drops 15 ml (twin pack), NDC number 76168-704-30.
CVS Health Multi-Action Relief Drops 15 ml, NDC number 76168-706-15.
CVS Health Lubricating Gel drops 10 ml, NDC number 76168-712-10.
CVS Health Lubricant Eye Drops 10 ml (single pack), NDC number 76168-714-10.
CVS Health Lubricant Eye Drops 10 ml (twin pack), NDC number 76168-714-20.
CVS Health Mild Moderate Lubricating Eye Drops 15 ml (single pack), NDC number 76168-711-15.
Rugby Lubricating Tears Eye Drops 15 ml, NDC number 0536-1282-94.
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml, NDC number 0536-1325-94.
Leader Dry Eye Relief 15 ml, NDC number 70000-0089-1.
Leader Lubricant Eye Drops 15 ml (single pack), NDC number 70000-0090-1.
Leader Dry Eye Relief 10 ml, NDC number 70000-0088-1.
Leader Eye Irritation Relief 15 ml, NDC number 70000-0087-1.
Rite Aid Lubricant Eye Drops 15 ml (twin pack), NDC number 11822-9707-5.
Rite Aid Lubricant Eye Drops 10 ml (twin pack), NDC number 11822-4811-3.
Rite Aid Gentle Lubricant Gel Eye Drops 15 ml, NDC number not provided.
Rite Aid Lubricant Gel Drops 15 ml, NDC number 11822-9706-5.
Rite Aid Lubricating Gel Drops 10 ml, NDC number 11822-4540-3.
Rite Aid Multi-Action Relief Drops 15 ml, NDC number 11822-2254-3.
Target Up&Up High Performance Lubricant Eye Drops 15 ml, NDC number 11673-522-30.
Target Up&Up High Performance Lubricant Eye Drops 15 ml (single pack), NDC number 11673-522-15.
Target Up&Up Dry Eye Relief 15 ml, NDC number 76168-800-30.
Velocity Pharma LLC Lubricant Eye Drop 10 ml (triple pack), NDC number 76168-502-30.
Walmart Equate Hydration PF Lubricant Eye Drop 10 ml, NDC number 79903-168-01.
Leader Lubricant Eye Drops 15 ml (twin pack), NDC numbers 70000-0090-2 (carton) and 70000-0090-1 (bottle).
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