Sun Pharmaceutical Industries Inc has recalled 144 bottles of a generic anti-depression medicine from the US market due to a manufacturing issue, according to the US Food and Drug Administration (USFDA).
The US-based subsdiary of the Mumbai-headquartered drug company initiated the recall for the affected lot of Bupropion Hydrochloride extended-release tablets due to "failed dissolution specifications,", the US health regulator said in its latest Enforcement Report.
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The affected lot was manufactured at Sun Pharma's Halol-based plant in Gujarat and was distributed in the US by Sun Pharmaceutical Industries Inc, based in Princeton, New Jersy, it said.
Bupropion is a medication commonly used to treat depression.
The US-based drug maker initiated the voluntary Class III nationwide (US) recall on October 4 this year.
As per the US FDA, 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".
Shares of Sun Pharma were trading at 0.73 per cent down at Rs 1,144.10 apiece on the BSE.
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