Brassica Pharma voluntarily recalls eye ointments over sterility concerns

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A select number of eye ointments available at Walmart and CVS locations around the country have been voluntarily recalled by Indian pharmaceutical manufacturer Brassica Pharma due to lack of sterility assurance. The Food and Drug Administration (FDA) noted the sterility issue during a facility inspection earlier this month, according to an FDA company announcement.

Brassica Pharma’s 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 products have expiration dates ranging from April 2024 to September 2025, and are sold in 3.5 gram tubes packaged in cardboard boxes.¹

The FDA cites that patients who have used the recalled Brassica Pharma eye ointments are at potential risk of eye infections or related harm, since the products are intended to be sterile. “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 stated in the announcement.

The FDA noted in its announcement that Brassica Pharma has not received any reports of adverse events related to the recall as of February 16.1 Brassica Pharma has been contacted to confirm that no adverse events have occurred since then, but have yet to respond.

As of February 16, Brassica Pharma has notified its distributor AACE Pharmaceuticals and retailers Walmart and CVS that retailers that receive recalled products should return them to the distributor, as well as ceasing all distribution of the affected product. Consumers who purchased the recalled eye ointment are also encouraged to return the products at their local retailer.¹

Those with questions regarding the recall can contact Brassica Pharma at 833-225-9564 or info@brassicapharma.com, and should contact their physician or healthcare provider if they experience any adverse side effects that may be related to using the affected product.¹

Those who have experienced adverse reactions or quality problems for this product can submit a report here.

Reference:

1. Brassica Pharma Pvt. Ltd. Issues Voluntary Nationwide Recall of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment Due to Potential Lack of Sterility. Food and Drug Administration. Company announcement. Published February 26, 2024. Accessed February 28, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/brassica-pharma-pvt-ltd-issues-voluntary-nationwide-recall-equate-lubricant-eye-ointment-equate-stye