The Food and Drug Administration on Monday announced the recall of multiple brands of eye ointment with concerns of possible contamination. The news comes amid recent claims of other tainted eye products and reports of antibiotic resistance.

Brassica Pharma Private Limited, the India-based pharmaceutical company that manufactured the ointment products, voluntarily recalled multiple brands on Feb. 12. As of Feb. 16, no adverse events have been reported to the FDA in relation to the recall.

The brands include:

• Equate Lubricant Eye Ointment
• Equate Stye Lubricant Eye Ointment
• CVS Health Lubricant Eye Ointment
• Lubricant PM Ointment

The recall involves multiple lot numbers, with products expiring in 2024 and 2025. Visit the FDA’s website for more specifics on the recalled products.

CVS Health, in an email statement on Tuesday, said it had stopped selling both CVS Health brand Lubricant Eye Ointment in stores and online in October 2023.

“Customers who purchased the product can return it to CVS Pharmacy for a full refund,” per the statement. “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.”

Monday’s alert was not the only recent eye-related news from the FDA. On Jan. 31, it warned of counterfeit eye drops and concerns of contamination.

Eye infections are particularly dangerous because the eye is less protected than other parts of the body.

“The body has natural protective mechanisms, like our skin, to keep things on the outside from getting inside,” said Daria Van Tyne, an assistant professor at Pitt School of Medicine’s Division of Infectious Diseases. The eye, though, is made of nervous tissue, she said, and is therefore a more direct route for bacteria to enter the body.

The FDA bought and tested the eyedrop brands South Moon and Rebright and concluded they were “copycat” versions of the legitimate brand Lumify. The brand FivFivGo was also found to be a counterfeit brand, but the FDA said it was unable to acquire the product for testing.

South Moon eye drops were contaminated with Burkholderia cepacia complex, a type of bacteria that is thought to confer antibiotic resistance. The FDA discovered that both South Moon and Rebright Rebright lacked brimonidine tartrate, the active ingredient in Lumify. It encouraged consumers not to buy any of the three brands and to discard products if consumers had already purchased them.

“[T]he agency has received reports related to possibly fake Lumify, including product quality concerns, eye irritation, pain and infection,” it wrote in the release. “The agency recommends consumers only buy eye products from reputable retailers such as state-licensed pharmacies and beware of online retailers selling products with false claims.”

Ms. Van Tyne sees the recent recalls as “emblematic of enhanced scrutiny” post-COVID-19. In May 2022, the Centers for Disease Control and Prevention and the FDA were alerted of a new drug-resistant bacterial strain called P. aeruginosa, which the CDC said had never before been identified in the U.S. The bacteria was linked to contamination in EzriCare artificial tears.

“That event was kind of a wakeup call,” said Ms. Van Tyne. “Post-COVID, there was definitely a lapse in oversight of many facilities. We are only now realizing the potential impact of the inability of the FDA to access these sites and conduct their investigations.”

The fact that the recent recalls involved a lack of “sterility assurance” — that is, potential contamination at the plant, and not yet confirmed contamination of the product — speaks to the proactivity of these agencies, she said.

“This is the system working as it should be working.”

Consumers should check their medicine cabinets for any of the aforementioned products and discard them immediately, said Ms. Van Tyne. If searching for alternative products, they should contact their eye doctor for recommendations.

Hanna Webster: hwebster@post-gazette.com 

First Published: February 28, 2024, 10:30 a.m.
Updated: February 29, 2024, 1:23 a.m.