Editorial Team
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Nearly 40,000 tubes of Fluorouracil topical cream, used to treat various skin conditions, has been recalled from the American market by Taro Pharmaceuticals USA Inc, the Israel -based subsidiary of Sun Pharmaceuticals.
Topical fluorouracil is used to treat certain cancerous or precancerous skin conditions including solar keratoses, actinic keratosis and superficial basal cell carcinoma in which cells are multiplying rapidly.
In its enforcement report, US Food and Drug Administration (USFDA) said that Taro Pharmaceuticals has voluntarily recalled 39,982 tubes of Fluorouracil Topical Cream USP from the US and Puerto Rico markets adding that the reason for the class II recall is that 'product lacks stability'.
Class II recalls, as per the USFDA, are done in a situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences or where there is a remote probability of serious adverse health consequences.
In September, 2010Mumbai-based firm Sun Pharma had acquired a controlling stake in Taro. It currently holds 66.5 per cent stake in Taro.