Sun Pharmaceutical Industries is recalling 31,762 bottles of bupropion hydrochloride extended- release tablets used for treatment of major depressive disorder in the United States due to failed dissolution specifications. The recall has been initiated for 31,762 bottles of bupropion hydrochloride extended-release tablets, USP (SR) in the strength of 150 mg.
This was a ‘Class III’ recall, initiated voluntarily by the company. Such a recall is initiated where use of or exposure to a violative product is not likely to cause adverse health consequences. The tablets were made by the company at its Halol (Gujarat) unit, already under an FDA scanner.
Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical company.
