Eye Ointment Products Recalled Nationwide Citing ‘Lack Of Sterility Assurance’
Indian pharmaceutical manufacturer Brassica Pharma has voluntarily recalled a number of eye ointment products sold nationally at Walmart and CVS locations due to "lack of sterility assurance."
According to Ophthalmology Times, Brassica Pharma has yet to receive or report adverse effects related to the recall as of Feb. 16. Since then, they have reportedly been contacted for any updates, but have yet to respond.
The list of recalled products include Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%, Lanolin Alcohols), Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid, Wheat Germ Oil), CVS Health Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid Wheat Germ Oil), and Lubricant PM Ointment.
Recalled items have expiration dates ranging between February and September 2025 and were sold in 3.5 gram tubes packaged in cardboard boxes.
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The Federal Drug Administration (FDA) flagged the issue and made the announcement on Feb. 22. They published a statement four days later following a facility inspection earlier this month.
"Thane, Maharashtra, India, Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration dates ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration (FDA)," the administration stated.
Patients that use compromised products may face potential risk of eye infections or related harm.
"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 FDA warned.
Over the past year, several eye products have reportedly been pulled from shelves due to unsanitary conditions at its manufacturing facility.
Eye products were also recalled in January, including South Moon, Rebright, and FivFivGo eye drops, as the FDA warned of increased risk of eye infection following use of the product.
The FDA has confirmed that as of Feb. 16, Brassica Pharma has notified its distributor AACE Pharmaceuticals and retailers Walmart and CVS that any recalled items received should immediately be returned to the distributor.
Anyone experiencing adverse reactions or quality problems regarding these products should contact Brassica Pharma at 833-225-9564 or info@brassicapharma.com.
The FDA provides all patients the opportunity to report serious problems anytime at their safety portal here.
