 The affected products were produced from June 2015 through September 2015.The contaminated products were distributed in the United States and worldwide, including in Canada and Australia.On March 16, 2016, the United States Food and Drug Administration, responding to recalls of contaminated products sold by Gilchrist and after inspecting its plant, issued a warning letter to the company noting violations of the Federal Food, Drug, and Cosmetic Act and mandating extensive corrective actions, resulting in a temporary shutdown of parts of Gilchrist's manufacturing plant.