Sun Pharma is recalling around 10,500 bottles of a generic drug meant for the treatment of major depressive disorders in the US market following a customer complaint. According to the latest enforcement report of the US Food and Drug Administration (FDA), the US arm of the domestic pharma major is recalling 10,548 bottles of bupropion hydrochloride extended-release tablets in the American market.
The drug is used to treat depression and prevent Seasonal Affective Disorder (SAD). It is also used to help people stop smoking. As per the FDA, the company is recalling the affected lot due to “presence of foreign substance: Customer complaint for the presence of dark, gritty substance found within the bottle, which was determined to be activated carbon from the desiccant canister inside the bottle.”
The drugmaker is recalling the product in 150 and 200 mg strengths, it added. The company is recalling 9,804 bottles of 150 mg strength and 744 bottles of 200 mg strength, the US health regulator stated.
The affected lot of the medication was manufactured by the drugmaker in its Halol (Gujarat)-based manufacturing plant. In the US, the medication was distributed by New Jersey-based Sun Pharmaceutical Industries. The company initiated the class-III nationwide (US) voluntary recall on 29th April this year.
As per 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.”
Earlier this month, Sun Pharma had said that the FDA issued a ‘Form 483’ with ten observations after inspecting its Halol plant in Gujarat. As per FDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The US health regulator conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from 26th April to 9th May, the Mumbai-based drugmaker had said in a regulatory filing.
Edits by EP News Bureau