The FDA has issued an alert warning about two eyedrop brands that may be contaminated and risk serious injury to users and may even cause vision problems.
USA Todaywrites, “The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. One person died and at least five others had permanent vision loss.
There’s no indication the latest recalls are related to those products.
The Food and Drug Administration posted separate recall notices for certain eyedrops distributed by Pharmedica and Apotex after the companies said they are voluntarily pulling several lots of their products from the market. Both companies said the recalls were conducted in consultation with the FDA.
Pharmedica on Friday said it is recalling two lots of Purely Soothing 15% MSM Drops due to problems ‘that could result in blindness.’ The over-the-counter drops are designed to treat eye irritation. The Phoenix-based company said consumers should immediately stop using the drops and return them to the place they were purchased.”
The recall impacts just under 3,000 bottles manufactured in Arizona.
Preservative-free artificial tears, like the ones recalled “can be an important treatment for people with chronic dry eyes, and they’re recommended for those who use artificial tears more than four times a day, according to the American Academy of Ophthalmology. That’s because the preservatives can actually further irritate the eyes.
But these preservative-free tears are usually sold in single-use packaging, not multiple-use bottles. Studies have found that multiple-use containers of preservative-free eye drops are prone to bacterial contamination, Consumer Reportsnoted.
“Multi-use preservative-free eye drop bottles have a higher risk of infectious contamination because, without antimicrobial preservatives, bacteria and fungus can proliferate potentially leading to sight-threatening infections,” Christopher Starr, MD, clinical spokesperson for the American Academy of Ophthalmology to CR. But using drops with preservatives several times a day can irritate the eye’s surface. He continued, “We generally recommend preservative-free drops in single-use disposable containers for most people.”
A privately held company based in Arizona, Pharmedica stated in the recall that it had yet to receive notifications of any illnesses related to the drops.
“Purely Soothing is used as an anti-inflammatory remedy to help with eye irritation or swelling. The product has been sold worldwide via e-commerce sites like Amazon, Pharmedica said. The drops come in white, cylindrical bottles with eye-dropper caps and a white lid. The Lot Numbers and UPC codes of the recalled products are:
Lot Number: 2203PS01, 1 oz, UPC 7 31034 91379 9;
Lot Number: 1808051, ½ oz, UPC 7 31034 91382 9
The FDA warned Americans on February 2 against using Delsam Pharma’s Artificial Eye Ointment, an over-the-counter eye drop from Global Pharma Healthcare of India. The product has been linked to a bacterial outbreak of Pseudomonas aeruginosa, which can cause eye infections for people who wear contact lenses, among other illnesses.
Global Pharma is the same manufacturer behind the EzriCare Artificial Tears Lubricant Eye Drops, which were also recalled last month,” reports CBS News.