The product is used for the treatment of depression, panic disorder and social anxiety disorder
Lupin’s US arm, Lupin Pharmaceuticals, is recalling 12,480 bottles of Paroxetine extended-release tablets on account of failed dissolution specifications from the US market.
Lupin Pharmaceuticals is recalling 12,480 bottles of Paroxetine extended-release tablets in the strength of 12.5 mg manufactured by Lupin at its Pithampur plant in Madhya Pradesh, the US FDA 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 the treatment of depression, panic disorder and social anxiety disorder.
According to the United States Food and Drug Administration (US FDA), the ongoing voluntary nationwide recall in the US is a class III recall.
According to the USFDA, 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.
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