MANILA, Philippines — The Food and Drug Administration (FDA) has ordered the recall from the market of two lots of an anti-gout medicine, declaring that the lots did not have enough active pharmaceutical ingredients.
In an advisory, the FDA directed all healthcare professionals and concerned establishments to discontinue the distribution and sale of Colchicine 500 microgram tablet with lot numbers PE09P and PF03P.
Colchicine is used for the treatment of acute gout and for short-term prophylaxis during initial therapy with allopurinol and uricosuric drugs.
“Based on the laboratory analyses, the product has insufficient quantity of the active pharmaceutical ingredient, and consumption may lead to underdosing and cause possible mistreatment,” the FDA reported.