FDA issues voluntary recall of certain eye drop brands sold online after fungal and bacterial contamination
The Food and Drug Administration (FDA) has issued a voluntary recall on certain eye drop brands that were found to have fungal and bacterial contamination.
The products from Dr Berne‘s include their MSM 5 per cent Solution Eye Drops, MSM 15 per cent Solution Eye Drops, Castor Oil Eye Drops; MSM MIST Drops 5 per cent Solution
“Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection. To date, Dr Berne’s has received 2 reports of adverse events related to this recall,” the FDA said in a statement on Saturday.
Earlier in the week, the FDA said that people should “properly discard” the products if they have purchased them and said: “Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection.”
Both products are sold online and are considered illegal because they contain an ingredient called methylsulfonylmethane, or MSM.
“These products are unapproved drugs and illegally marketed in the US. There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient,” the agency added.
MSM is a compound that is used widely in alternative medicine and is also sometimes used to treat arthritis – it has not been approved for use in eye drops.
There have been no reports of injuries so far but the contaminated eyedrops could pose a serious risk to consumers. However, the FDA said people “who have signs or symptoms of an eye infection should talk to their health care professional or otherwise seek medical care immediately.”
The FDA tested the products and found that they had been contaminated with microbes and were not sterile.
“Under the Federal Food, Drug and Cosmetic Act, eye drops must be sterile to be safe for use,” it added.
Dr Berne’s MSM Drops 5 per cent Solution has a bacterial contamination known as Bacillus and a fungus called Exophiala.
The LightEyez drops contained three kinds of bacterial contamination: Pseudomonas, Mycobacterium, Mycolicibacterium and Methylorubrum.
The agency said due to this, Dr Berne “verbally agreed” on 21 August 21 to “voluntary recall” the Dr Berne’s MSM Drops 5 per cent Solution.
The FDA said it emailed LightEyez Limited to discuss its concerns with their products. LightEyez has not yet responded to the FDA.
Earlier this year, four people died, while others were reported to have gone blind due to a drug-resistant bacteria found in recalled eyedrops.
At the time, the US Centres for Disease Control and Prevention released an update on Friday (19 May), alerting the public to a rise in deaths and injuries caused by the bacteria.
Eighty-one patients in 18 states have been affected by the bacteria after using EzriCare or Delsam Pharma’s Artificial Tears products, the Centers for Disease Control and Prevention said.
The contaminated products, made by the India-based company Pharma Healthcare, were recalled in February, with at least seven patients diagnosed afterwards. In addition to the four deaths, 14 individuals have gone blind and four others had their eyes surgically removed.
A visit by US health inspectors to the factory uncovered failures to maintain sterility.
