The U.S. Food and Drug Administration this week warned CVS Health Corp.
CVS,
Walgreens Boots Alliance Inc.
WBA,
and several smaller consumer products companies about marketing unapproved eye products. “The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the FDA said in a release Tuesday. In a letter to Walgreens dated Monday, the agency said several eye-drop products offered on the company’s website, including drops for allergies and pink eye, are unapproved new drugs whose delivery through interstate commerce may violate federal law. The FDA’s letter to CVS contained similar warnings about “CVS Health Pink Eye Relief Drops” offered through the CVS website. Both letters also raised concerns about the manufacturing practices of contract manufacturers producing the products. The FDA asked the companies to notify the agency of steps taken to correct the violations within 15 working days. CVS said in a statement that on receipt of the FDA letter it stopped the sale of the CVS Health brand pink-eye relief drops at stores and online, and customers who purchased the product can return it for a full refund. “We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers,” CVS said. Walgreens did not immediately respond to requests for comment. CVS shares gained 0.7% Tuesday, while Walgreens stock was up 0.6%.
