Certain eye drops are being recalled after testing by federal health officials showed that the product was contaminated with bacteria and fungi.
Dr. Berne’s Whole Health Products issued a recall for all lots of MSM DROPS 5%,15% Solution as well as Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM MIST 15% Solution, according to a recall notice posted by the U.S. Food and Drug Administration (FDA).
The recall was initiated after an FDA analysis found one lot of one of the eye drop solutions failed "sterility with both bacterial and fungal contamination found in the product," according to the notice.
Contaminated eye drops could cause minor to serious "vision-threatening" infections, which could "possibly progress to a life-threatening infection," the notice read.
The company already received two reports of "adverse events" that are related to the recalled drops. The notice didn't specify what those adverse events were.
Dr. Berne’s MSM MIST Drops 15% Solution. (FDA)
Consumers are instructed to stop using the recalled drops. The company said it's also notifying distributors and customers through email and arranging for the return of its affected eye drops.
The notice is the latest in a string of recent eye drop warnings due to sterility. According to the National Library of Medicine, eye drops need to be sterilized "to ensure they are free of microbial contamination."
In March, Apotex Corp. initiated a voluntary recall for select lots of Brimonidine Tartrate Ophthalmic Solution, 0.15%, "out of an abundance of caution due to cracks that have developed in some of the units caps."
The broken caps could impact "sterility and if so, the possibility of adverse events," the FDA said.
Similarly, Pharmedica USA LLC voluntarily recalled some of its Purely Soothing, 15% MSM Drops due to non-sterility.
The recalled products have not been associated with the outbreak of infections tied to the use of the artificial tears manufactured by Global Pharma Healthcare, according to the FDA.
In February, Delsam Pharma’s Artificial Eye Ointment and all lots within expiry of the EzriCare and Delsam's artificial tears products were recalled over possible contamination.