Sun Pharma arm recalls 144 bottles of anti-depression medicine in US over manufacturing issue

Published On 2023-10-20 06:07 GMT | Update On 2023-10-20 06:24 GMT

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...

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".

Read also: Sun Pharma Cequa Phase 4 data shows sustained improvement in Dry Eye Disease signs, symptoms in patients switched from Restasis

Medical Dialogues 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.

Read also: Aurobindo Pharma, Sun Pharma recall Rasagiline Tablets, Cequa from US market

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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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Sun Pharma arm recalls 144 bottles of anti-depression medicine in US over manufacturing issue

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