New Delhi: Drug major Sun Pharmaceutical Industries is recalling over 16,000 bottles of 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 US Food and Drug Administration (FDA) said.
The Class III recall is due to "failed dissolution specifications", the report on the website of the US health regulator (FDA) said.
According to the US 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".