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The Food and Drug Administration (FDA) issued a warning to consumers not to use certain kinds of eyedrops as they may include unapproved medications that cannot be sold legally in the US and may be infected with bacteria, fungus, or both.
Consumers were advised not to use Dr Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops, according to a warning placed on the FDA’s website.
“Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection,” the FDA announced in the recall issued last Tuesday.
Methylsulfonylmethane, also known as MSM, is an active component in eye drops that, the FDA claims, is not licenced in the US as an eye medication and that the eye drops were improperly advertised.
The FDA has found that both eyedrop brands were contaminated with five different strains of bacteria while fungal contamination was discovered in Dr Berne’s product, violating a federal law that requires eye drops to be sterile for human use.
The FDA is advising everyone who uses eye drops to check them and discard them if they are one of the impacted products. Customers should stay away from those items in stores, CBS affiliate, KREM reported.
Dr Berne officials told the FDA on August 21 that they would voluntarily recall the MSM drops, followed by an announcement on Saturday recalling all Dr Berne’s MSM Drops 5% Solution, 15% Solution, Dr Berne’s Organic Castor Oil Eye Drops and Dr Berne’s MSM Mist 15% Solution.
The recall notice did not state how serious the incidents were, but the company claimed it had received two complaints of unfavourable events associated with it.
The FDA said it has been unable to reach LightEyez Limited, and the company has not responded to emailed messages trying to discuss the safety concerns.
“To date, LightEyez has not responded to FDA or taken action to protect consumers,” the FDA wrote in a statement.
Contaminated eye drops can cause severe infections, potentially threatening vision and life. Users are advised to seek medical help immediately after using either product and submit complaints to the FDA’s MedWatch Adverse Event Reporting program if they experience adverse reactions.
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