The US Food and Drug Administration has issued a warning to Amazon for selling several brands of eye drops that the agency considers “unapproved new drugs.”
On Monday, the FDA issued a warning letter addressed to Amazon CEO Andrew Jassy, saying the e-commerce website had tested positive for seven brands marketed as treatments for conditions such as pink eye, dry eyes, dust irritation and cataracts. Was selling eye drops.
As a result, the agency says, the products could be classified as “new drugs” that Amazon is distributing without FDA approval.
The brands included in the letter are Similasan Pink Eye Relief, The Goodbye Company Pink Eye, Can-See Eye Drops, Optic 1 Eye Drops, Oclumed Eye Drops, TRP Natural Eyes Floaters Relief and Manzanilla Sophia Chamomile Herbal Eye Drops.
Amazon says it has begun removing products from its online marketplace.
“Safety is a top priority at Amazon,” a spokesperson said in a statement. “We require that all products offered in our stores comply with applicable laws and regulations. The products in question have been investigated and are in the process of being removed.
According to the letter, Amazon’s sale and distribution of the eye drops — which the FDA says are “not generally accepted as safe and effective” — without the agency’s prior approval violates the Federal Food, Drug, and Cosmetic Act. and is a violation of the United States Code. ,
“These products are of particular concern from a public health perspective,” the FDA letter said. “Ophthalmic drug products, which are meant to be instilled into the eye, generally pose a greater risk of harm to users because the route of administration of these products bypasses some of the body’s natural defenses.”
Monday’s warning letter comes after others from the FDA issued warnings about the eye drops.
In October, the agency warned that 26 over-the-counter eye drop products, sold under store brands including CVS, Target, Walmart and Rite Aid, could cause eye infections that result in vision loss or blindness. Could.
Although the eye drops are supposed to be sterile, the agency reported that the facility where the drops were manufactured had “unsanitary conditions” and “positive bacterial test results from environmental sampling of critical drug production areas.”
CVS, Rite Aid and Target removed the products from store shelves and websites. Cardinal Health, whose six Leader Brand eye drops were on the FDA list, issued a recall for the products in early November.
On Wednesday, Mumbai-based Kilich Healthcare India Ltd, which manufactured the eye drops affected by the October recall, also issued a recall for all eye drops on the FDA’s warning list.
Earlier this year, the FDA warned against using several other eye drop products due to contamination with bacteria or fungus.
In February, the US Centers for Disease Control and Prevention urged health care providers and patients to avoid using Ezricare eye drops after investigating bacterial contamination linked to more than 80 infections in 18 states.
The infection involved a rare strain of the drug-resistant bacteria Pseudomonas aeruginosa, which has never been identified before in the US. Four deaths were reported, as well as 14 cases of vision loss and four cases in which the eyeball had to be surgically removed.