Eye ointment products sold at CVS and Walmart stores nationwide are being recalled due to the potential risk of infection, federal health officials said.
Brassica Pharma Pvt. The company announced the recall after the Food and Drug Administration (FDA) found a “lack of sterility assurance” at its manufacturing facility, according to a notice posted on the agency’s website.
The four affected products are intended to be sterile and are sold under the brand names Equate, CVS Health, and AACE Pharmaceuticals, and have expiration dates from February 2024 to September 2025. .
The product was distributed nationwide through wholesalers, retailers, and product distributors Walmart, CVS, and AACE Pharmaceuticals Inc.
“Patients using these products are at potential risk of eye infections or related harm,” the recall notice reads.
In particular, “ophthalmic medications may pose an increased potential risk of harm to users because the drugs applied to the eye bypass some of the body’s natural defenses,” the notice continued. .
As of February 16, the company has not received any reports of adverse events related to the recalled products.
CVS announced that the company has discontinued sales of CVS Health Lubricant Eye Ointment in 3.5 gram tubes, supplied by Brassica Pharma Pvt. Ltd., both online and in stores. Became a corporation in October.
“Customers who purchased the product can return it to CVS Pharmacy for a full refund,” CVS said in a statement to FOX Business. “We are committed to ensuring that the products we offer are safe, work as intended, and satisfy our customers, and we are cooperating fully with the FDA on this matter.”
FOX Business has reached out to Walmart and AACE Pharmaceuticals Inc. for comment.
Still, the company has told distributors and retailers to “stop distributing the product.” It also asks consumers to stop using the affected products and return them.
Over the past year, several eye care products have been removed from shelves and recalled due to unsanitary conditions at manufacturing facilities.
In November 2023, Kilic Healthcare India Limited voluntarily recalled 27 eye drops, all of which are on the FDA’s rolling list of products that may be contaminated with bacteria. posed a risk of eye infections and vision loss.
This is the third recall in recent weeks, according to a previous FDA warning notice, and follows similar notices from Cardinal Health and its subsidiary, Harvard Drug Group LLC.
The recalls come after the FDA warned users in late October to avoid certain products from the brands CVS Health, Leader, Rugby, Rite Aid, Target’s Up & Up, Velocity Pharma and Equate.
None of the recalls mentioned above are related to an outbreak of Pseudomonas aeruginosa, an antibiotic-resistant bacteria, associated with Global Pharma Healthcare’s ophthalmic products.
