Eyedrops Recall: Some Brands May Not Be Sterile, Says FDA

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Eyedrops Recall: Some Brands May Not Be Sterile, Says FDA

The Food and Drug Administration (FDA) issued several recall notices for two brands of eyedrops that may not be sterile and could lead to extensive vision problems and serious injury.

The recall affects certain eyedrops distributed by Pharmedica and Apotex, and follows a February recall which was linked to a multi-state outbreak of drug-resistant infections. That outbreak caused the death of one person and left at least five others with permanent vision loss, according to ABC News.

While no injuries or illnesses have been reported from the latest recalled products “using contaminated artificial tears increases risk of eye infections that could result in blindness or death,” says the FDA.

Both Pharmedica and Apotex said they are voluntarily pulling several lots of their products from the market in conjunction with discussions being had with the FDA.

Based in Arizona, Pharmedica’s recall is for two lots of its “Purely Soothing 15% MSM Drops” which are over-the-counter drops that are designed to treat general irritation. The company is urging consumers to halt the use of the medicine immediately due to non-sterility issues that “could result in blindness.”

The recall affects nearly 2,900 bottles that were distributed “via online e-commerce and Trade shows (Ex. Amazon Marketplace, Etc.).”

The Apotex recall is for six lots of “Brimonidine Tartrate Ophthalmic Solution, 0.15%,” which are prescription eyedrops primarily used to treat a form of glaucoma. The affected products were sold between April 2022 through February of this year, said the company.

Apotex, based out of Florida, says the notice was “being initiated out of an abundance of caution due to cracks that have developed in some of the units caps,” which “may impact sterility and if so, the possibility of adverse events.”

Both companies are urging wholesalers and retailers to stop distributing the recalled products and advise any consumer who may have used the contaminated drops to seek medical attention should symptoms appear.

Medical Daily Source