Zydus Pharmaceuticals USA Inc is recalling over 16 thousand bottles of Bupropion Hydrochloride tablets manufactured by Ahmedabad-based Cadila Healthcare on account of failure to meet the desired dissolution specifications.
Around 16,356 bottles of Bupropion Hydrochloride extended release tablets in the strength of 300 mg are being recalled by Zydus Pharmaceuticals USA Inc, the latest Enforcement Report of the USFDA said.
Bupropion hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder.
As per the report, the reason for recall is, "Failed Dissolution Specifications; 6 month time point".
The voluntary ongoing nationwide recall is a class III recall, the report by United States Food & Drug Administration (USFDA) said.
As per the US health regulator, 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".
Zydus Pharmaceuticals USA Inc is the US arm of Zydus Cadila's listed entity Cadila Healthcare.
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