Lupin recalls 12,480 bottles of anti-depressant drug from US
New Delhi: Drug firm Lupin's US arm, Lupin Pharmaceuticals Inc, is recalling 12,480 bottles of Paroxetine extended-release tablets on account of failed dissolution specifications from the US 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 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.
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