New Delhi: Cadila Healthcare’s US arm, Zydus Pharmaceuticals USA Inc, is recalling 44,800 bottles of antidepressant Paroxetine tablets from the American market, the US health regulator said in a report.
In its latest Enforcement Report, United States Food and Drug Administration (USFDA) has said Zydus Pharmaceuticals USA Inc is recalling the Paroxetine tablets in the strength of 30 mg, manufactured by Cadila Healthcare Ltd.
The reason for the recall is the presence of foreign tablets. “Risperidone tablets were found in bottle of paroxetine tablets”, the report said.
The voluntary ongoing nationwide recall is a class II recall, it added.
As per the USFDA, a class II recall is initiated in a “situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.