Brassica Pharma recalls eye ointment products due to lack of sterility assurance

Key Takeaways

• Brassica Pharma has recalled Equate Lubricant Eye Ointment, Equate Style Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, and Lubricant PM ointment due to potential lack of sterility.
• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using the ointments.

Brassica Pharma has initiated a voluntary recall of its eye ointment products after an FDA inspection of a Brassica facility found a “lack of sterility assurance.”  “For those patients who use these products, there is a potential risk of eye infections or related harm. These 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,” according to a press release.

The 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.

These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Walmart, CVS and AACE Pharmaceuticals Inc.  No adverse events related to the recall have been reported. Consumers with questions regarding this recall can contact Brassica Pharma Pvt. Ltd. at +1 833-225-9564 or info@brassicapharma.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Consumers may report issues to the FDA’s MedWatch Adverse Event Reporting program.

Edited by Dawn Wilcox, BSN, RN and Miriam Kaplan, PhD

Sources:  

Healio Primary Care Optometry News, March 7, 2024; see Healio article Brassica Pharma company announcement, February 22, 2024; see announcement