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Amazon pulls seven eye drop products in response to FDA warning letter

Amazon has voluntarily pulled seven eye drop brands off their shelves in response to a warning letter issued by the Food & Drug Administration over potential safety concerns. 

The eye drops, marketed as a homeopathic treatment for pink eye, dry eyes, cataracts, irritation as a result of dust or other allergens are considered “new drugs” that have yet to be formally approved for sale by the FDA, according to the warning notice. 

The warning letter comes after the agency has recalled batches of eye drop products over the last couple of weeks, including over two dozen eye drop products sold by CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target, Velocity Pharma, and Walmart were recalled “after FDA investigators found insanitary conditions,” USA Today previously reported. 

Other eye drop products have been recalled in previous months, once in August and another time in February due to possible contamination, infections, vision loss, a handful of deaths and other adverse conditions, CNN reported. 

The online retail giant has already begun the process of removing any trace of these products from their site. 

“Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations. The products in question have been investigated and are in the process of being removed,” a company spokesperson shared with CNN. 

Here’s what we know.

Warning: FDA recalls another 27 eye drop products: What you need to know as a consumer

What eye drop products did Amazon voluntarily recall? 

What makes the sale and distribution of these ophthalmic products especially concerning is that they pose a greater risk of harm “because the route of administration for these products bypasses some of the body’s natural defenses,” according to the FDA. 

The recalled products are not “generally recognized as safe and effective” based on the claims for intended use. 

Therefore, they are classified as “new drugs” by the FDA. New drugs can’t be introduced or delivered for introduction into interstate commerce without an approved application from the FDA. 

Here’s a list of the recalled products: 

  • Similasan Pink Eye Relief
  • The Goodbye Company Pink Eye
  • Can-C Eye Drops
  • Optique 1 Eye Drops
  • OcluMed Eye Drops
  • TRP Natural Eyes Floaters Relief
  • Manzanilla Sophia Chamomile Herbal Eye Drops

What should I do if I have already consumed the product?

If you show any sign or symptom of a potential infection, the FDA has recommended consumers to immediately speak to their health care provider or or seek medical attention quickly. 

Adverse reactions to eye drops like discharge, redness or pain can indicate an infection. People should also check a product’s expiration date before use, spokesperson for the American Academy of Ophthalmology Dr. Christopher Starr shared with CBS.

Consumers should also properly discard of the eye drop products, according to guidelines set forth by the FDA.  Eye drop product users that experience a severe reaction as the result of a recalled product can file a report online with FDA. 

Eye drop recall list: See the dozens of eye care products recalled in 2023

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