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USFDA issues warning letter to eight companies for unapproved ophthalmic products.

 The US Food and Drug Administration released a warning notice to eight ophthalmic manufacturers for producing and selling unauthorised drugs, thereby violating federal law. The FDA states that these letters are part of ongoing efforts to protect citizens from potentially harmful eye products.

The agency noted that they are worried about illegally marketed, unauthorised drugs containing silver, which can cause grey or blue-grey discolouration of skin and body tissues, including the eye, called "argyria." The unauthorised drugs, claiming to treat the diseases may alter safe and effective medical treatment.

The FDA informed patients to use these products under the supervision of healthcare professionals and to report if they experience any adverse events.

US-based Boiron, Inc. received a notice for Optique 1 Eye Drops; CVS Health got an FDA warning for its CVS Health Pink Eye Relief Drops; and OcluMed LLC. received a warning letter from the FDA for OcluMed eye drops. DR Vitamin Solution, an ophthalmic company, received a letter for vision clarity eye drops, life extension brite eyes III, can-c eye drops, longevity science, and visual acuity. The Walgreens Boots Alliance, Inc. gets a warning for Walgreens allergy eye drops, stain eye drops, and pink eye drops.

Similarly, Similasan AG/Similasan USA got a letter for their 13 products; TRP Company, Inc. received a warning for their 12 preparations; and Natural Ophthalmic, Inc. got a warning for their 6 ophthalmic products.

The Director of the Office of Compliance in the Centre for Drug Evaluation and Research (CDER) at the USFDA, Jill Furman, said, "The FDA is committed to ensuring the medicines Americans take are safe, effective, and of high quality. When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations."

"We will continue to investigate potentially harmful eye products and work to ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern," she added.

The FDA has requested a response from all the companies within 15 days, describing the corrective actions taken to address this issue. If the company fails to respond, the FDA will take legal action.

As per a report, in response to the warning letter, CVS Health said, "Upon receipt of the FDA's Warning Letter, we have stopped the sale of CVS Health Brand Pink Eye Relief Eye Drops at our stores and online."

In their statement, TRP Company denied any adverse effects associated with their products and stated that "homoeopathic products are not illegally marketed."

Walgreens Boots Alliance said, "Out of an abundance of caution, we are pulling these products. Customers who have purchased these products can return the item to their nearest Walgreens for a full refund."

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