More eye products recalled over infection risk worries

More eye products recalled over infection risk worries

Four eye ointments have been recalled after federal inspectors raised sterility concerns at a manufacturing facility, adding to a growing list of eye products that have been recalled in recent months.

The voluntary recall involves four eye ointment products made by Brassica Pharma with expiration dates ranging from February 2024 to September 2025. The brands include two Equate eye ointments, a Walmart brand and eye ointment brands from CVS Health and AACE Pharmaceuticals.

No injuries related to the potentially unsterile conditions have been reported, Brassica Pharma said in a news release.

Eyedrop warnings and recalls have been in the news over the past several months, prompting worry and confusion among users. The Food and Drug Administration has said it has increased its scrutiny of eye-care products. Because eye-care products are applied directly into the eye, bypassing many of the body’s natural defenses, any potential contamination is a serious health risk.

The facts

The eye ointments being recalled all come in 3.5 gram tubes, which are packaged in a cardboard box. The recalled ointments include:

• Equate Lubricant Eye Ointment, with UPC code 681131395298
• Equate Stye Lubricant Eye Ointment, with UPC code 681131395304
• CVS Health Lubricant Eye Ointment, with UPC code 050428634141
• Ace Pharmaceuticals Lubricant PM Ointment, with UPC code 371406124356

The company said there is a potential risk of eye infections or related harm for patients who use these products. Consumers can find specific lot numbers and additional information in the company news release.

Background

Last fall, the FDA warned consumers to avoid more than two dozen eye-care products after finding bacterial contamination at manufacturing facilities. No injuries were reported at the time of the warnings.

In a separate case last year, federal officials announced two voluntary recalls after an outbreak of serious bacterial infections that affected 81 patients in 18 states. That outbreak resulted in at least 14 cases of vision loss, an additional four patients with enucleation (surgical removal of the eyeball), and four deaths, according to the Centers for Disease Control and Prevention.

The most serious reports were linked to “preservative-free” products. Preservative-free products contain mostly saline and distilled water. Many eyedrop brands contain chemical preservatives such as benzalkonium chloride, or BAK, as well as other ingredients.

When buying eyedrops or eye ointments, consumers should always check the expiration date and be careful to keep the drops or tube sterile when using them. “Don’t keep drops that are expired,” said T. Mark Johnson, a retina specialist who practices in Rockville, Md., and Fredericksburg, Va. “Cap them after use and try not to inadvertently contaminate the cap. Be sure to use the proper technique when putting the drops in your eye — take your finger, pull down the lower eyelid, and put the drops in without touching the bottle to your skin or eyelashes.”

If you are using eyedrops or ointments and you notice you have sudden pain, or a decrease in vision, you should contact your eye doctor.