Lupin Recalls 12,480 Bottles of Antidepressant Drug From U.S.

Pharma & Healthcare Monitor Worldwide

July 21, 2017

Drug firm Lupin’s U.S. arm, Lupin Pharmaceuticals Inc., is recalling 12,480 bottles of Paroxetine extended-release tablets on account of failed dissolution specifications from the U.S. market.

Lupin Pharmaceuticals Inc. is recalling 12,480 bottles of Paroxetine extended-release tablets in the strength of 12.5 mg manufactured by Lupin Ltd. at its Pithampur plant in Madhya Pradesh, the United States Food and Drug Administration (USFDA) said in its latest Enforcement Report.

The reason for the recall is “failed dissolution specifications: out of specification observed in dissolution testing at 3-month long term stability study,” the report added.

The product is used for treatment of depression, panic disorder and social anxiety disorder.

As per the USFDA, the ongoing voluntary nationwide in the U.S. recall is a class III recall.

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