Eye ointment products sold at CVS and Walmart stores nationwide are being recalled due to a potential risk of infection, federal health officials said.
Brassica Pharma Pvt. Ltd. issued the recall after the Food and Drug Administration (FDA) discovered a “lack of sterility assurance” at the manufacturing facility, according to a notice posted on the agency’s website.
The four impacted products, which are intended to be sterile, are sold under the brand names Equate, CVS Health and AACE Pharmaceuticals, and have expiration dates ranging from February 2024 to September 2025.
The products were distributed nationwide to wholesalers, retailers and through the product distributor, Walmart, CVS and AACE Pharmaceuticals Inc.
“For those patients who use these products, there is a potential risk of eye infections or related harm,” the recall notice read.
In particular, “ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the notice continued.
As of Feb. 16, the company has not received any reports of adverse events related to the recalled products.
CVS said the company stopped the sale, both online and in-stores, of CVS Health Lubricant Eye Ointment in a 3.5-gram tube supplied by Brassica Pharma Pvt. Ltd 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 the products we offer are safe, work as intended, and satisfy customers, and are fully cooperating with the FDA on this matter.”
FOX Business reached out to Walmart and AACE Pharmaceuticals Inc. for comment.
Still, the company is telling distributors and retailers to “cease distribution of the product.” It is also asking consumers to stop using the affected products and to return them.
Over the past year, several eye products were pulled from shelves and recalled due to unsanitary conditions at a manufacturing facility.
In November 2023, Kilitch Healthcare India Limited voluntarily recalled 27 eyedrops, all of which were listed on the FDA’s rolling list of products that may be contaminated with bacteria, posing a risk of eye infection and vision loss.
It marked the third recall in recent weeks and follows a similar notice from Cardinal Health Inc. and its subsidiary, Harvard Drug Group LLC, according to an earlier FDA warning notice.
Those recalls were prompted after the FDA warned users in late October to avoid certain products under the brands CVS Health, Leader, Rugby, Rite Aid, Target’s Up & Up, Velocity Pharma and Equate.
None of the aforementioned recalls have been tied to the outbreak of antibiotic-resistant bacteria pseudomonas aeruginosa linked to eye products by Global Pharma Healthcare.
