Several types of eye care products that have been recalled by the U.S. Food and Drug Administration, such as eye lubricant gels and eye drops, have been shipped out to consumers up until last month — here’s what you should know.
The FDA announced last week that it has classified five different previously recalled eye care products, intended to relieve eye dryness, as a Class II recall. The agency labels recalled products as Class II when it believes the “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The voluntary recall, which was initiated by the manufacturer, BRS Analytical Services, LLC, was announced by the FDA last month. The agency stated at the time that the products were being recalled due to deviations of cGMP, or Current Good Manufacturing Practices. The FDA also cited a “lack of assurance of sterility” as reason for the recall. More than 75,000 cases of products in total were affected.
The products in question were distributed by pharmaceutical healthcare distributor AvKARE. The company said in a statement that the “health hazard to the user is unknown.”
