Brassica Pharma recalls eye ointment products due to lack of sterility assurance
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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.
Brassica Pharma has notified AACE Pharmaceuticals, Walmart and CVS of the recall.
No adverse events related to the recall have been reported. Consumers may report issues to the FDA’s MedWatch Adverse Event Reporting program.
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