New Delhi: Sun Pharma is recalling over 2.7 lakh bottles of bupropion hydrochloride extended-release tablets used for treatment of major depressive disorder in the US due to failed dissolution specifications.
The recall is being initiated by Sun Pharmaceutical Industries Inc. for 2,71,212 bottles of bupropion hydrochloride extended-release tablets, USP (SR) in the strengths of 150 mg and 200 mg, US Food and Drug Administration (USFDA) said in its latest Enforcement Report.
While 150 mg strength tablets are in 60, 100 and 500 count bottles, the 200 mg tablets are in 11,618 bottles bottles of 60 count, it added. The tablets have been manufactured by Sun Pharma at its Halol plant in India.
The ongoing nationwide voluntary recall is on account of “failed dissolution specifications; 18 month stability time point”, the report said, adding that it is a class III recall. As per the 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.”