FDA issues recall of eye drop products due to infection risk
US health chiefs have alerted consumers about two recalls of eye drop products due to contamination concerns that could lead to adverse events. The Food and Drug Administration (FDA) announced that the contaminated batches may carry a risk of vision problems or serious injury, though no such events have been reported to date. The announcement, however, comes amid a recent outbreak of infections due to bacterial contamination of different eye care products.
Several recalls of eye drops have been issued in recent weeks over sterility and expiration concerns.
The latest recalls come soon after an eye product was recalled in India last month due to an outbreak of drug-resistant infections.
One person died and at least five others had permanent vision loss, according to Associated Press News.
The Centers for Disease Control and Prevention sent out a health alert to doctors at the time, saying the outbreak included at least 55 people in 12 states.
It is still not known whether the latest recalls are in any way related to those products, however.
The FDA recently posted separate recall notices for certain eye drop products distributed by Pharmedica and Apotex.
The notice reads: “Use of the contacted eye drops can result in the risk of eye infections that could result in blindness.”
The announcement was made after the two companies said they are voluntarily pulling several lots of their products from the market, following consultations with the FDA.
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Pharmedica announced on Friday that it recalled two lots of Purely Soothing 15 percent MSM Drops, due to problems that “could result in blindness”.
The products, which are sold through trade shows and online marketplaces like Amazon, are being recalled worldwide.
Consumers using the over-the-counter drops – designed to treat eye irritation – have been advised by Pharmedica to discontinue their treatment.
“To date, Pharmedica USA LCC has not received any reports of adverse events or illness related to this recalled product,” said the FDA.
The recall affects approximately 2,900 bottles that were manufactured in Arizona, US, according to the Phoenix-based company.
The FDA also announced last week that Apotex was recalling six lots of prescription eye drops used to treat a form of glaucoma.
The company announced it initiated the recall “out of an abundance of caution due to cracks that have developed in some of the unit’s caps”.
According to the FDA, the broken caps may impact “sterility and if so, the possibility of adverse events”.
The voluntary recall concerned selected lots of Brimonidine Tartrate Ophthalmic Solution, 0.15 percent.
Apotex told AP News that it has not yet received any reports of injury related to the eye drops, which were manufactured in Canada.
The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation or swelling, according to the FDA.
Wholesalers and retailers distributing the affected products have also been instructed to discontinue distribution immediately.
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