(Bloomberg) -- Over-the-counter eye drops sold by CVS Health Corp., Walgreens Boots Alliance and six other companies are illegally marketed and pose a public health concern to Americans, US regulators said in warning letters Tuesday.

A deadly bacterial outbreak was linked to other eye drop products earlier this year. 

The US Food and Drug Administration said it considers the eye drops to be unapproved new drugs that are in violation of federal law. Some of the eye drops, including ones marketed by CVS and Walgreens, were manufactured by companies known to have quality issues related to product sterility. The names of those contract manufacturers were redacted.

CVS and Walgreens have stopped selling the eye drops named in the warning letter and customers who have purchased them can get refunds, the companies said.

“We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers,” CVS said in a statement. 

A visit to CVS in downtown Boston revealed five boxes of the store-brand pink eye drops included in the warning in stock on Tuesday morning, but the store’s system blocked them from being purchased. It also blocked the sale of a similar eye drop product from Similasan AG, a Swiss company that was among those that received the warning letters Tuesday. 

Boiron Inc., DR Vitamin Solutions, Natural Opthalmics, Inc., OcluMed LLC and TRP Company, Inc. were also sent warnings. “These warning letters are part of the agency’s ongoing effort to protect Americans from potentially harmful ophthalmic products,” the FDA said in a statement. 

Read More: Untested, Bacteria-Tainted Eyedrops Blinded and Killed Americans

 

A representative from Boiron said the FDA did not cite safety issues or quality concerns about its eye drops and said the product has been sold in the US since 1995. OcluMed has never received a “medically verified complaint” of bad reactions and stands behind its product, a spokesperson said in an email. A TRP spokesperson said no reported health concerns have been linked to its ophthalmic products. The other companies that the FDA warned had no comment or didn’t respond.

The agency appears to be increasing its surveillance of eye drop products after a deadly bacterial outbreak earlier this year was linked to products made in India. Several deaths, more than a dozen cases of vision loss and scores of infections were linked to contaminated eye drops from EzriCare LLC and Delsam Pharma LLC.  

Last month, the FDA issued warnings about two more brands because of “bacterial contamination, fungal contamination, or both.” One of them was later recalled. The agency said it “conducted sampling and testing based on these products’ intended use in the eyes, and due to the industry’s recent manufacturing issues with eye drops.”

KC Pharmaceuticals Inc, a contract manufacturer for eye drops based in California, was also issued a warning letter in August for significant violations of good manufacturing practices, including that the company does not operate an effective quality oversight system. On its website, KC Pharmaceuticals says it’s the largest supplier of private label eye care products in North America, servicing 26 out of 30 top retailers. 

The companies that received Tuesday’s warning letters have been asked to respond to the FDA within 15 days stating how they will correct the violations. Failure to correct the violations promptly may result in the FDA pursuing legal action, including product seizure or a court order requiring a company to stop manufacturing and distributing an unapproved product, the FDA said. The agency also placed some of these companies on import alert to help stop their products from entering the US. Similasan AG is one of the companies on the import alert list.

--With assistance from John Tozzi, Peter Robison, Ike Swetlitz and Fiona Rutherford.

(Updates with additional company responses in the fourth and ninth paragraphs)

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