FDA Eye Drop Recalled: Contaminated Eye Drops & Linked to Deaths

[2024] FDA Eye Drop Recalled: Contaminated Eye Drops & Linked to Deaths

February 2024: FDA Warns Consumers of Contaminated Copycat Lumify Eye Drops

Avoid South Moon, Rebright, and FivFivGo Eye Drops

In a recent announcement, the FDA has issued a stern warning to consumers regarding the use of South Moon, Rebright, and FivFivGo eye drops due to potential risks of eye infection.

These eye drops, masquerading as Bausch + Lomb's Lumify brand, are unauthorized and pose serious health hazards to consumers. Lumify, an FDA-approved over-the-counter product designed for redness relief, bears no resemblance to these imposter eye drops.

Lumify Eye Drops
It's critical to note that South Moon, Rebright, and FivFivGo eye drops have NOT undergone FDA approval and should not be available for purchase within the United States. Moreover, these products claim to treat conditions like glaucoma, a serious eye ailment requiring prescription medication or surgical intervention.

In laboratory testing, South Moon eye drops were found to be contaminated with Burkholderia cepacia complex, a group of bacteria capable of causing antibiotic-resistant infections. Although Rebright samples tested negative for contamination, the FDA still cautions against their use.

The origins of these counterfeit products remain uncertain, prompting ongoing investigations by the FDA. Notably, South Moon is purportedly manufactured by Shantou Cross-border Premium Products E-Commerce Co. Ltd. in China.

While the FDA has not received any reports of adverse events specifically attributed to South Moon, Rebright, or FivFivGo products, incidents related to potentially counterfeit Lumify have been reported. These include concerns regarding product quality, eye irritation, pain, and infections.

To safeguard their health, consumers are advised to purchase eye products exclusively from reputable retailers, such as state-licensed pharmacies. Caution is also advised when shopping online, as counterfeit products with false claims may be prevalent.

November 2023: UK - Medicines and Healthcare products Regulatory Agency (MHRA): Urgent Recall: Safety Concerns Prompt Recall of Specific Carbomer Eye Gels

Critical recall notice for specific batches of carbomer eye gels.

The affected products below distributed after August 2023, with product code CB048G1H

  • AACARB eye gel
  • AACOMER eye gel
  • PUROPTICS eye gel

Affected lot numbers/serial numbers: 3H02, 3H03, 3H04, 3H05, 3H06, 3H07, 3H08, 3H09, 3H10, 3H11, 3I02. 3I03, 3J07, 3J08, 3J09, 3J23, 3J24, 3K01, 3K02.

The eye gel brands are manufactured by Indiana Ophthalmics and distributed by Trion Pharma, Essential-Healthcare and Biovantic Pharma, respectively.

The recall is in response to a potential risk of microbiological contamination, specifically Burkholderia cenocepacia, prompting precautionary measures to ensure public safety.

The UK Health Security Agency (UKHSA) is actively investigating this matter, with ongoing testing to assess the extent of the risk. While the general risk to the public is deemed very low, specific patient groups, such as those with cystic fibrosis, are considered at higher risk of adverse effects.

All patients and customers are advised to immediately stop using the affected batches of the recalled eye gels and return them to the place of purchase. If any concerns arise about health in relation to the recall, contacting a healthcare professional is crucial. Individuals with cystic fibrosis or those awaiting lung transplantation and using carbomer-containing eye gels are specifically advised to cease use and seek advice from their respective healthcare providers.

aacarb carbomer 0.2 eye gel

aacarmer carbomer 0.2 eye gel

Puroptics carbomer 0.2 eye gel

October 2023: FDA Alert: Avoid 26 Over-the-Counter Eye Drop Products Due to Eye Infection Risk

The FDA issues a crucial warning to consumers concerning 26 over-the-counter eye drop products, urging them not to purchase or continue using these items. This action is prompted by the potential threat of eye infections that could lead to partial vision loss or even blindness. If you experience any signs or symptoms of an eye infection after using these products, it's essential to consult your healthcare provider or seek immediate medical attention.

These products are available under various brand names:

  • CVS Health
    • Lubricant Eye Drops 15 ml (single pack)
    • Lubricant Eye Drops 15 ml (twin pack)
    • Lubricant Gel Drops 15 ml (single pack) 
    • Lubricant Gel Drops 15 ml (twin pack)
    • Multi-Action Relief Drops 15 ml
    • Lubricating Gel drops 10 ml
    • Lubricant Eye Drops 10 ml (single pack)
    • Lubricant Eye Drops 10 ml (twin pack)
    • Mild Moderate Lubricating Eye Drops 15 ml (single pack) 
  • Leader (Cardinal Health)
    • Dry Eye Relief 10 ml
    • Lubricant Eye Drops 15 ml (single pack)
    • Lubricant Eye Drops 15 ml (twin pack)
    • Dry Eye Relief 15 ml
    • Eye Irritation Relief 15 ml
  • Rugby (Cardinal Health)
    • Lubricating Tears Eye Drops 15 ml    
    • Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml
  • Rite Aid
    • Lubricant Eye Drops 15 ml (twin pack)
    • Lubricant Eye Drops 10 ml (twin pack)
    • Gentle Lubricant Gel Eye Drops 15 ml
    • Lubricant Gel Drops 15 ml
    • Lubricating Gel Drops 10 ml
    • Multi-Action Relief Drops 15 ml
  • Target Up & Up
    • Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml
    • Up&Up Extreme Relief Dry Eye 15 ml (single pack)
    • Up&Up Extreme Relief Dry Eye 30 ml (twin pack)
  • Velocity Pharma
    • Lubricant Eye Drop 10 ml (triple pack)
  • Walmart
    • Equate Hydration PF Lubricant Eye Drop 10 ml

On October 25, 2023, the FDA recommended that the manufacturer of these products recall all lots. This action was taken after agency investigators discovered unsanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas. Additionally, the FDA advises consumers to dispose of these products correctly."

September 2023: FDA issues warning over unapproved Similasan Eye Drops

The U.S. Food and Drug Administration (FDA) has issued a stern warning to Similasan citing violations of federal law in the marketing of unapproved eye products.

These eye products are being unlawfully promoted as remedies for conditions such as cataracts, glaucoma, and conjunctivitis. The FDA has raised serious concerns, pointing out that some of these products are labelled to contain silver, and their prolonged use may lead to the permanent discoloration of skin and body tissues, including the eyes, resulting in a grey or blue-grey hue.

Similasan eye drops

  • Similasan's ophthalmic products, including those marketed under various names like "Similasan Dry Eye Relief" and "Similasan Pink Eye Relief," are considered unapproved new drugs under federal law. These products are not recognized as safe and effective for their intended uses, making their marketing and distribution a violation of the Federal Food, Drug, and Cosmetic Act.

August 2023: 2 Eye Drops Recalled! 

The FDA has issued a warning to consumers about two more eye drop products to be recalled. The FDA has identified that these products are contaminated with bacteria or fungi, or both. Using contaminated eye drops can lead to eye infections that range from minor to severe, and in some cases, these infections could become life-threatening.

  • Dr. Berne’s MSM Drops 5% Solution - contain an active ingredient called methylsulfonylmethane (MSM). These products have not been approved by the FDA as drugs and are illegally being marketed in the United States.
    • Dr. Berne’s MSM Drops 5% Solution is being voluntarily recalled by Dr. Berne as of August 21, 2023.
Dr. Berne’s MSM Drops 5% Solution
  • LightEyez MSM Eye Drops – Eye Repair - contain an active ingredient called methylsulfonylmethane (MSM). These products have not been approved by the FDA as drugs and are illegally being marketed in the United States.
    • The FDA has also reached out to LightEyez Limited to discuss their concerns about the contaminated eye drops, but LightEyez has not responded or taken any action to address the issue at this time

LightEyez MSM Eye Drops – Eye Repair

What is methylsulfonylmethane (MSM)?

MSM is a sulfur-containing compound that has been shown to have anti-inflammatory and antioxidant properties.

MSM eye drops are marketed for a variety of eye conditions, including dry eye, blepharitis, and conjunctivitis. However, there is limited scientific evidence to support the use of MSM eye drops for these conditions.

The FDA has not approved any ophthalmic drugs that contain MSM as an active ingredient. Therefore, the safety and effectiveness of MSM eye drops have not been established.

January - February 2023: 3 Eye Drops Recalled!

Several brands of eye drops were recalled due to contamination concerns. The recalls affected a total of four products:

  • EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears were recalled in January after they were linked to a drug-resistant strain of the bacteria Pseudomonas aeruginosa. Infections from this bacteria strain have caused at least four people’s deaths, vision loss in 14 others, and the surgical removal of four people’s eyeballs.

Recalled Eyedrop - Ezricare Artificial Tears

  • Brimonidine Tartrate Ophthalmic Solution 0.15% was recalled by Apotex on March 1 after at least four bottle caps developed cracks, which could affect the product’s sterility.

Recalled Eyedrop - Brimonidine Tartrate Ophthalmic Solution

  • Purely Soothing 15% MSM Drops was recalled by Pharmedica on March 3 after it was found that the drops were not sterile.

Recalled Eyedrop - Purely Soothing 15% MSM Drops

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are urging people who have used any of the recalled eye drops to stop using them and to see a doctor if they have any symptoms of an eye infection. Symptoms can include yellow, green or clear discharge from the eye, redness of the eye or eyelid, increased sensitivity to light, and eye pain or discomfort.

If you have any of the recalled eye drops, you should:

  • Stop using them immediately.
  • Contact your health care provider and pharmacy.
  • Request a “recall/return packet” from the manufacturer.

Here are some additional tips to help you stay safe from eye drop contamination:

  • Always wash your hands before and after using eye drops.
  • Do not share eye drops with anyone.
  • Store eye drops in a cool, dark place.
  • Do not use eye drops if the bottle is damaged or expired.

By following these tips, you can help reduce your risk of getting an eye infection from contaminated eye drops.

Reference: CDC Reporting here

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