New Delhi: Drug major 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.
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".
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team had earlier reported that leading drug makers Sun Pharmaceutical Industries and Aurobindo Pharma had announced the recall of medications indicated for treating dry eye and Parkinson's disease from the US market.
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Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult-to-make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs), and Intermediates.
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