The class III recall is due to 'failed dissolution specifications', the report on the website of United States Food and Drug Administration (USFDA) said.
Drug major Sun Pharmaceutical Industries is recalling over 16,000 bottles of an anti-depressant tablets from the US market due to failed dissolution specifications.
The buPROPion hydrochloride extended release tablets were manufactured at the company’s Halol facility.
Sun Pharmaceutical Industries Inc, the company’s US subsidiary, is recalling 16,085 bottles of buPROPion hydrochloride extended release tablets in the strength of 150 mg in a ongoing voluntary nationwide recall, the latest Enforcement Report of the USFDA said.
The class III recall is due to ‘failed dissolution specifications’, the report on the website of United States Food and Drug Administration (USFDA) said.
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”.