Taro Pharmaceuticals, the Israel -based subsidiary of Sun Pharmaceuticals, has recalled nearly 40,000 tubes of Fluorouracil topical cream, used to treat various skin conditions, from the American market.
Taro Pharmaceuticals USA Inc has voluntarily recalled 39,982 tubes of Fluorouracil Topical Cream USP from the US and Puerto Rico markets, US Food and Drug Administration (USFDA) said in its enforcement report.
The reason for the class II recall is that 'product lacks stability', it added.
As per the USFDA, class II recalls are done in a situation in which 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.
Sun Pharma had acquired a controlling stake in Taro in September, 2010. The Mumbai-based firm currently holds 66.5 per cent stake in Taro.
Topical fluorouracil is used to treat certain skin conditions in which cells are multiplying rapidly. It is used to treat cancerous or precancerous conditions including solar keratoses, actinic keratosis and superficial basal cell carcinoma.