The US Food and Drug Administration (FDA) has issued warning letters to eight companies including Walgreens Boots Alliance Inc (NASDAQ:WBA) and CVS Health Corp (NYSE:CVS) for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.
The eye products addressed in the eight warning letters are illegally marketed to treat conditions such as conjunctivitis (pink eye), cataracts, glaucoma and others, The FDA said in a news release.
Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility.
“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality,” commented Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research.
“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 told the companies to respond within 15 days of receipt of the letters, stating how they will correct the violations.
Failure to correct the violations promptly may result in legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing an unapproved product, it said.
“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 added.
According to a Reuters report, 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.
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