Sun Pharma recalls 144 bottles of anti-depression drug from U.S. market

Sun Pharma recalls 144 bottles of anti-depressant from US due to manufacturing issue. Bupropion Hydrochloride extended-release tablets failed dissolution specifications. The recall initiated by US-based subsidiary of Mumbai-headquartered drug company was voluntary and Class III nationwide. Shares of Sun Pharma trading 0.73% lower.

Sun Pharmaceutical Industries Inc has recalled 144 bottles of a generic anti-depression medicine from the U.S. market due to a manufacturing issue, according to the U.S. Food and Drug Administration (FDA).

The U.S.-based subsdiary of the Mumbai-headquartered drug company initiated the recall for the affected lot of Bupropion Hydrochloride extended-release tablets due to “failed dissolution specifications,” the U.S. health regulator said in its latest Enforcement Report.

The affected lot was manufactured at Sun Pharma’s Halol-based plant in Gujarat and was distributed in the U.S. by Sun Pharmaceutical Industries Inc, based in Princeton, New Jersy, it said.

Bupropion is a medication commonly used to treat depression.

The U.S.-based drug maker initiated the voluntary Class III nationwide (US) recall on October 4 this year.

As per the U.S. 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.”

Shares of Sun Pharma were trading 0.73% lower at ₹1,144.10 apiece on the BSE.