FDA issues warning letters to 8 companies for marketing unapproved eye products
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The FDA has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products, the agency announced in a press release.
In an effort to protect U.S. consumers from potentially harmful eye products, the FDA addressed those that have been illegally marketed to treat conditions such as conjunctivitis, cataracts and glaucoma. Some of the warning letters also cited quality issues related to product sterility.
The companies that received warning letters are Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan AG/Similasan USA, TRP Company and Walgreens Boots Alliance.
“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality,” Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, said in the release. “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.”
The FDA requested that the companies respond within 15 days of receiving the letters and include a plan to correct the violations. Should the companies fail to comply, the FDA plans to pursue legal action, which may include product seizure and a court order to stop the manufacturing and distribution of an unapproved product. Some companies were also placed on import alert to keep their products from entering the U.S.
“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,” Furman said in the release.
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