About 10,500 bottles of a generic drug designed to treat major depressive disorder in the U.S. market were recalled by pharmaceutical company Sun Pharma following a customer complaint.
The U.S. Department of Homeland Security’s department is recalling 10,548 bottles of extended-release bupropion hydrochloride tablets in the U.S. market, according to the latest enforcement report from the U.S. Food and Drug Administration (USFDA).
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 foreign substance: Customer complaint for the presence of dark, gritty substance found in the bottle, which was determined to be activated carbon from the desiccant container inside the bottle”.
The drug manufacturer is recalling the product in strengths of 150 and 200 mg, it added.
The company is recalling 9,804 bottles with a strength of 150 mg and 744 bottles with a strength of 200 mg, the US health authority said.
The affected batch of the medicine was manufactured by the pharmaceutical manufacturer in its Halol (Gujarat) -based production plant. In the United States, the drug was distributed by New Jersey-based Sun Pharmaceutical Industries Inc.
The company initiated Class III nationwide (US) voluntary recall on April 29 this year.
According to the USFDA, a Class III recall is initiated in a “situation where the use of or exposure to an infringing product is unlikely to cause adverse health consequences.”
Earlier this month, Sun Pharma had said the USFDA issued a ‘Form 483’ with ten observations after inspecting its Halol plant in Gujarat.
According to the US FDA, a Form 483 is issued to a company’s management at the conclusion of an inspection when the investigator has observed conditions that, in its opinion, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related laws.
The U.S. Department of Health and Human Services conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from April 26 to May 9, the Mumbai-based drugmaker had said in a regulatory application.
The Mumbai-based Sun Pharmaceutical Industries is the fourth largest specialized generic pharmaceutical company in the world with a global turnover of over $ 4.5 billion.
With over 40 manufacturing facilities, it sells medicines in over 100 countries across the globe.
With PTI inputs