October 13, 2016 1:43:31 am
Sun Pharmaceutical has initiated a nationwide recall of 31,762 bottles of its antidepressant drug Bupropion Hydrochloride Extended Release tablets in the United States after the drug failed to meet “dissolution specifications” in Food and Drug Administration (FDA) tests.
The dissolution test measures the time taken by the drug to disintegrate and absorb in the blood stream. The medicine was manufactured in the company’s Halol plant which received a warning letter from USFDA in December, 2015. The information about the ongoing drug recall was made public by USFDA through its latest “enforcement report”.
The present action is a class 3 recall — a situation in which “use of or exposure to a violative product” is not likely to cause adverse health consequences, according to USFDA. According to Sun Pharma’s 2015-16 annual report, it is the fifth largest generics company in the US with one of the largest Abbreviated New Drug Applications pipeline and a portfolio of over 400 approved products. In 2015-16, the company earned 48 per cent of its revenue (Rs 13,516 crore) from the United States market itself.
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