FDA issues warning letters to CVS, Walgreens, other companies over unapproved eye products

The U.S. Food and Drug Administration issued letters to a number of companies — together with primary pharmacy chains — this week, warning them in opposition to production or promoting unapproved eye products.

Letters were sent to CVS and Walgreens as well as six manufacturers claiming the products are illegally advertised as being ready to deal with stipulations together with cataracts, glaucoma and crimson eye.

Some of the letters additionally addressed high quality regulate issues on the companies regarding the protection and sterility of the products.

Nearly 3 weeks in the past, the FDA warned the general public no longer to use to positive products due to fears of possible bacterial or fungal contamination.

In their letters, the FDA additionally mentioned other folks the use of those unapproved eye products that declare to deal with or remedy positive stipulations would possibly motive lengthen or stoppage of remedies which can be licensed by way of the company.

“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality,” Jill Furman, director of the place of business of compliance on the FDA’s Center for Drug Evaluation and Research, mentioned in a commentary. “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,” the commentary persevered.

The FDA informed the companies they’ve 15 days to reply to the FDA in writing to cope with any steps they’ve taken to proper violations.

A listing of the products used to be no longer indexed at the FDA site, however a spokesperson informed ABC News the products have been named within the particular person letters.

For CVS, the FDA noted CVS branded “Pink Eye Relief Drops” declare to relieve redness, burning, watery discharge and emotions of grittiness.

However, the product is unapproved and, in accordance to the FDA, would possibly motive hurt as it comprises silver sulfate as a preservative, which is able to motive everlasting bluish-gray discoloration of the eye in addition to lowered evening imaginative and prescient.

“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,” a CVS spokesperson informed ABC News in a commentary. “Customers who purchased this product can return it to CVS Pharmacy for a full refund. We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers. “

For Walgreens, the FDA cited three store brand products together with “Allergy Eye Drops,” “Stye Eye Drops,” and “Pink Eye Drops” all of which declare to deal with signs reminiscent of itching, redness, burnings and watery discharge. The company had the similar fear about silver sulfate.

“Out of an abundance of caution, we are pulling these products,” Walgreens informed ABC News in a commentary. “Customers who have purchased these products can return the item to their nearest Walgreens for a full refund.”

In a letter to Swiss corporation, Similasan AG, the FDA famous the corporate no longer simplest has 12 unapproved products but in addition had recorded high quality regulate violations. This incorporated no longer following procedures to save you microbiological contamination and whole information to be had to be sure specs and requirements have been met.

Similasan AG has no longer replied to ABC News’ request for remark.

The FDA recommends that any one who bought the products indexed within the warning letters to discuss with a well being care skilled and document any antagonistic reactions to the MedWatch program.