Regulatory 10,500 bottles of U.S anti-depression drug recalled by Sun...

10,500 bottles of U.S anti-depression drug recalled by Sun Pharma

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Sun Pharmaceutical has recalled over 10,000 bottles of its anti-depression drug in the U.S due to customer complaints. The generic anti-depression drug is used to treat serious depressive episodes in patients.

Sun Pharmaceuticals is an Indian generic drug manufacturing company with a wide global reach, spanning over 100 countries. The company is the fourth-largest generic drug manufacturer in the world. 

The oral anti-depression drug is an extended-release tablet of bupropion hydrochloride sold in the U.S. market. The latest U.S. Food and Drug Administration (USFDA) report stated that the medicine will be recalled by the company’s American division, with over 10,000 bottles becoming part of the recall. 

Among the medicine, Sun Pharma is recalling the 150mg and 200mg tablets. 9,800 of the 150mg strength and 700 of the 200mg strength bottles are in the process of being recalled from the U.S. market.

The recalled medicine is prescribed in the treatment of severe episodes of depression and used in the prevention of Seasonal Affective Disorder. 

The USFDA explained that the medicine has to be recalled due to customer complaints. It was concluded after the investigation that a foreign substance was found in the medicine. 

One such customer complaint detailed that there was a dark-colored substance in the bottle, which was later found to be activated carbon. The carbon came from a desiccant canister present in the tablet bottle. As per USFDA the affected medicine is not likely to cause any detrimental reactions due to exposure.

The recall is termed a Class III recall which is stated as a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”

The medication was distributed by Sun Pharmaceutical’s New Jersey distributor, while the drug itself was manufactured in Gujrat in India at the company’s manufacturing plant.

The recall is voluntary by Sun Pharma and is to take place across the U.S. and was the result of the USFDA issuing a form after inspecting the Gujrat plant. The USFDA Form 483 made ten observations after which the company opted for a voluntary recall.

A U.S. health regulatory authority inspected the Gujrat facility for Good Manufacturing Practices compliance, from late April to early 

May of 2022. Subsequently,  Form 483 is provided to the management of the company after inspection by the USFDA is completed. This is done in the case where the investigation finds violations of regulatory acts. 

Being one of the largest generic drug manufacturers in the world, Sun Pharma generates revenues of over $4.5B and has distribution across 100 countries made possible by its over 40 pharmaceutical manufacturing plants.

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