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Amazon said on Wednesday that it was removing seven eyedrops products from its website after the Food and Drug Administration warned the company that the eyedrops had not been recognized as safe and effective. said in a letter to Andrew Jassy, Amazon’s chief executive, on Monday that Amazon had violated federal regulations by selling the eyedrops, which claimed to help with problems including pink eye, dry eyes, eyestrain and floaters. “These products are especially concerning from a public health perspective,” the F.D.A. letter said. “Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.”The eyedrops named in the letter are: 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, and Manzanilla Sophia Chamomile Herbal Eye Drops.
Persons: Andrew Jassy, Manzanilla Sophia Organizations: Food and Drug Administration, Amazon, Eye
REUTERS/Pascal Rossignol/File Photo Acquire Licensing RightsNov 15 (Reuters) - Amazon (AMZN.O) said on Wednesday it was in the process of removing seven unapproved eye drops from its e-commerce platform following a warning letter from the U.S. health regulator earlier this week. The U.S. Food and Drug Administration (FDA) on Monday sent a warning letter to Amazon for selling eye drops which have not been recognized as safe and effective in providing temporary relief from symptoms such as excessive watery discharge, redness, burning and pink eye. The eye drops flagged in the letter to Amazon include Similasan Pink Eye Relief, Can-C Eye Drops, Optique 1 Eye Drops and OcluMed Eye Drops, among others. The FDA has warned consumers against using 26 over-the-counter eye drops due to risk of infection and some cases of possible vision loss. The health agency also sent warning letters to eight other companies in September, including pharmacy giants CVS Health (CVS.N) and Walgreens Boots Alliance (WBA.O), against manufacturing or marketing of certain unapproved eye products.
Persons: Pascal, Bhanvi, Shounak Dasgupta Organizations: REUTERS, U.S . Food, Drug Administration, Monday, Eye, FDA, CVS Health, Walgreens Boots Alliance, Thomson Locations: U.S, Bengaluru
US FDA warns Amazon against sale of unapproved eye drops
  + stars: | 2023-11-14 | by ( ) www.reuters.com   time to read: +1 min
REUTERS/Brendan McDermid/File Photo Acquire Licensing RightsNov 14 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it had sent a warning letter to Amazon.com (AMZN.O) related to sale of seven unapproved eye drops on the company's e-commerce platform. In the letter dated Nov. 13, FDA said Amazon was selling eye drops which have not been recognized as safe and effective for providing temporary relief from eye symptoms such as excessive watery discharge, redness, burning, or pink eye. Eye products generally pose a greater risk of harm to consumers as they bypass some of the body's natural defenses, the agency said. The seven products flagged in the letter to Amazon include Similasan Pink Eye Relief, Can-C Eye Drops, Optique 1 Eye Drops, OcluMed Eye Drops, among others. In September, FDA warned eight companies, including pharmacy giants CVS Health (CVS.N) and Walgreens Boots Alliance (WBA.O), against manufacturing or marketing of certain unapproved eye products.
Persons: Brendan McDermid, Privately, Similasan, Bhanvi, Shounak Dasgupta Organizations: Amazon, REUTERS, U.S . Food, Drug Administration, FDA, Eye, CVS Health, Walgreens Boots Alliance, Thomson Locations: New York City, U.S, Bengaluru
FDA warns CVS, others against selling unapproved eye products
  + stars: | 2023-09-12 | by ( ) www.reuters.com   time to read: +2 min
CVS Health logo is seen displayed in this illustration taken, May 3, 2022. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing RightsSept 12 (Reuters) - The U.S. Food and Drug Administration on Tuesday warned eight companies, including pharmacy giants CVS Health Corp (CVS.N) and Walgreens Boots Alliance (WBA.O), against manufacturing or marketing unapproved eye products. Some of the these eye products were labeled to contain silver, the FDA said, adding that long-term use of drugs containing silver can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray. CVS and Walgreens said they have stopped the sale of the unapproved eye drops, and that customers who purchased these products could return them for a full refund. The FDA warned that failure to correct the violations may result in legal action, including product seizure and court orders requiring the companies to stop manufacturing and distributing an unapproved product.
Persons: Dado Ruvic, Similasan, Leroy Leo, Mariam Sunny, Christy Santhosh, Pooja Desai, Maju Samuel Organizations: CVS, REUTERS, U.S . Food, Drug Administration, CVS Health Corp, Walgreens Boots Alliance, FDA, Walgreens, Reuters, Thomson Locations: U.S, Swiss, Bengaluru
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