According to the latest US Food and Drug Administration (USFDA) law enforcement report, the US branch of the national pharmaceutical major is recalling 10,548 bottles of bupropion hydrochloride extended-release tablets from the US market.
The drug is used to treat depression and prevent seasonal affective disorder (SAD). It is also used to help people quit smoking.
According to the USFDA, the company is recalling the affected lot due to “presence of a foreign substance: Customer complaint of a dark, gritty substance found in the bottle, which was determined to be activated carbon from the desiccant cartridge inside the bottle”. .
The drugmaker is recalling the product in the 150 and 200 mg dosages, he added.
The company is recalling 9,804 150mg vials and 744 200mg vials, the US health regulator said.
The affected batch of the drug was manufactured by the drug manufacturer at its manufacturing facility based in Halol, Gujarat. In the United States, the drug was distributed by a company based in New Jersey
The company initiated the nationwide (US) voluntary Class III recall on April 29 of this year.
According to the USFDA, a Class III recall is initiated in a “situation in which use of or exposure to an offending product is not likely to result in adverse health consequences.”
Earlier this month, Sun Pharma said the USFDA issued a “Form 483” with ten observations after inspecting its Halol factory in Gujarat.
According to the US FDA, a Form 483 is issued to a company’s management at the end of an inspection when the investigator has observed conditions that, in their opinion, may constitute violations of the Food Drug and Cosmetic Act ( FD&C) and related laws.
The US health regulator carried out a good manufacturing practices (GMP) inspection of the Halol factory from April 26 to May 9, the Mumbai-based drugmaker said in a regulatory filing.
Mumbai-based Sun Pharmaceutical Industries is the world’s fourth largest specialty generic pharmaceutical company, with global revenues of over $4.5 billion.
With over 40 manufacturing plants, it sells drugs in over 100 countries around the world.