Zydus Pharma Inc recalls 9,504 bottles of Risperidone tablets
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.
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.
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