Cadila Healthcare has recalled over 20,500 bottles of anti-depressant Bupropion Hydrochloride extended release tablets from US markets made by the company. The Class III ongoing nationwide and Puerto Rico recall is initiated in a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), the reason for the recall is failed dissolution specifications: the firm was notified that there was dissolution out of specification result on the 6 month stability samples.
Cadila Healthcare is part of the Zydus Cadila Group. The company operates in areas of active pharmaceutical ingredients (API) to formulations, and animal health products to cosmeceuticals. Over the last five decades, it has been developing and manufacturing pharmaceutical products and selling and distributing these in over 50 countries around the world.