New Delhi: Zydus Pharmaceuticals USA Inc is recalling 9,504 bottles of antipsychotic Risperidone tablets made in India by the group firm Cadila Healthcare on account of ‘out of specification for a known degradant’.
The ongoing Class III US nationwide including Puerto Rico voluntary recall is for Risperidone orally disintegrating tablets in the strength of 2 mg, United States Food and Drug Administration (USFDA) said in it’s Enforcement Report for the week of March 2.
“The reason for recall is “out of specification for a known degradant,” it added.
A class III recall by the US health regulator is initiated in a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Risperidone tablets are used in the treatment of schizophrenia.
Zydus Pharmaceuticals (USA) Inc is the US division of Cadila Healthcare.