Topline
Recalls for four eye ointments sold at major retailers like CVS and Walmart were issued this week after an investigation found their facility was unsterile, as the Food and Drug Administration warns unsterile eye products have a heightened risk of causing infection.
Key Facts
The ointments were recalled after the FDA conducted an inspection at the India-based facility they were made in and found there was a “lack of sterility assurance,” according to a recall announcement posted Monday by the FDA.
Brassica Pharma, the manufacturer of the ointments, warned of a potential risk for eye infection and other harms if these products are used, though it noted it hasn’t received any reports of adverse reactions as of February 16.
The recalled products include two from Walmart’s generic brand Equate, a CVS Health eye product and an AACE Pharmaceuticals eye lubricant.
The ointments have expiration dates ranging from February 2024 to September 2025, and Brassica Pharma is advising customers to stop using the products and return them to their place of purchase.
The products are intended to temporarily treat eye irritations like burning, dryness, stinging, itching, discomfort or exposure to the sun or the wind.
Brassica Pharma did not immediately respond to Forbes’ request for comment.
Key Background
These eye ointments are ophthalmic drug products—medications that are meant to be sterile and used on the eyes. These drugs have to be sterile because they pose an increased risk of infection since drugs applied to the eyes bypass the body’s natural defenses, according to the FDA. Early eye infection symptoms include itchiness, swelling, red or watery eyes and eye pain. Later-stage symptoms include blurred vision, yellow discharge from the eyes, fever, sensitivity to light and eyelashes that clump together due to discharge. The FDA has issued four other recall notices for eye products since August. The most recent one was issued on January 31 and involved copycat products sold under the brand names South Moon, Rebright and FivFivGo. They were mistaken for the Lumify eyedrops sold by Bausch + Lomb. Though the FDA didn’t receive any adverse event reports, it did note South Moon products tested positive for a group of bacteria called Burkholderia cepacia, and neither South Moon nor Rebright products contained brimonidine tartrate, the active ingredient in Lumify. Manufacturer Kilitch Healthcare India Limited issued voluntary recalls for around 30 eyedrops in November after FDA investigators found unsanitary conditions that may cause infection. The FDA sent warning letters to eight companies in August for illegally selling eye products marketed to treat eye conditions like pink eye, glaucoma and cataracts. Dr. Berne’s Whole Health Products recalled all of its MSM Drops 5% and 15% Solution Eye Drops in August due to fungal and bacterial contamination. The company received two adverse event reports, and the FDA also warned the products are unapproved in the U.S. and being illegally sold.
Tangent
The Centers for Disease Control and Prevention reported a string of drug-resistant bacterial infections from recalled eye products last May, which resulted in at least 81 infections, 14 people who went blind and four deaths.
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