FDA Announces Eyedrop Recalls


The recalled products | Image by FDA

The Food and Drug Administration (FDA) has issued new warnings to consumers regarding two unrelated recalls of eyedrops, citing contamination risks that could result in vision issues and severe harm.

Pharmedica and Apotex have both voluntarily pulled several of their products from the market, prompting the FDA to post separate recall notices.

On March 2, the FDA announced the recall of six lots of Apotex’s Brimonidine Tartrate Ophthalmic Solution 0.15%. The Canadian company initiated the recall after discovering that some of the units’ caps had developed cracks, thereby putting the medication’s sterility in question.

The affected products, which were distributed between April 05, 2022, and February 22, 2023, can be identified by their NDC numbers. These prescription eye drops are used to manage open-angle glaucoma and ocular hypertension.

The notice concerning Pharmedica’s Purely Soothing 15% MSM Drops was released the following day. Two lots were recalled for “lack of sterility,” which may cause adverse reactions including blindness. These over-the-counter drops are designed to treat eye irritation.

The Phoenix-based company advises consumers to stop using the drops immediately and return them to where they were purchased. The recall affects nearly 2,900 bottles, per AP News.

These recalls follow the previous month’s announcement by the FDA that Artificial Tears Lubricant Eye Drops produced by Dubai-based Global Pharma Healthcare in India had possibly been contaminated. The recall covered all unexpired lots of the product.

The eye drops, marketed in the United States by EzriCare, were linked to the outbreak of drug-resistant infections that affected as many as 55 people in 12 states, including Texas, per The Dallas Express. While the medication is administered to the eyes, the infection was found in the blood, urine, and lungs of some patients.

As WFAA reported, one man in Washington was killed, while five other people suffered permanent vision loss associated with these infections.

This outbreak was linked to Pseudomonas aeruginosa, a type of bacteria known to cause multiple infections in different parts of the body. It is typically found in water or soil, and most people contract it after having surgery.

While the authorities have detected Pseudomonas aeruginosa in open EzriCare bottles, the outbreak is still being investigated, per WFAA. For its part, EzriCare has stopped distributing the eye drops and posted a warning on its website.

Last month, lots of Fabuloso cleaning products produced by Colgate-Palmolive for retailers like Family Dollar were also recalled due to possible contamination with this same bacteria, as The Dallas Express previously reported.

In the case of the latest eye drop recalls, both Pharmedica and Apotex said, per AP News, that no infections resulting from the use of their products have been reported as of yet.

The recalls were supposedly issued out of an abundance of caution and both companies are working in concert with the FDA on the matter.

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21 days ago

Pseudomonas aeruginosa – That seems kind of odd…to have that show up in various products.

Mercury and eyedrops
Thiomersal (also called thimerosal) is a mercury containing organic molecule that has been widely used as preservative for vaccines and eye drops. Other applications of this substance have been for ear drops, storage and cleaning solutions for contact lenses, and in tattoo inks.