Sun Pharmaceutical Industries is recalling 2,71,212 bottles of bupropion hydrochloride extended-release tablets, USP (SR) in the strengths of 150 mg and 200 mg from US market due to failed dissolution specifications. As per the US Food and Drug Administration (USFDA), a class III recall is initiated in a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The tablets have been manufactured by Sun Pharma at its Halol plant in India. The said tablet is used for treatment of major depressive disorder. While 150 mg strength tablets are in 60, 100 and 500 count bottles, the 200 mg tablets are in 11,618 bottles of 60 count.
Sun Pharmaceutical Industries is an Indian multinational pharmaceutical company that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States.