Zydus Pharmaceuticals USA Inc is recalling 9,504 bottles of antipsychotic Risperidone tablets made in India by the group's firm Cadila Healthcare, stated the U.S. Food and Drug Administration (USFDA) in it's Enforcement Report for the week of March 2.
The recall is happening on account of "out of specification for a known degradant". The ongoing Class III voluntary recall across the U.S. and Puerto Rico is for Risperidone orally disintegrating tablets of 2 mg strength. A Class III, according to the USFDA website, happens because the product is "unlikely to cause any adverse health reaction, but violates FDA labelling or manufacturing laws. Examples include: a minor container defect and lack of English labelling in a retail food."
Risperidone tablets are used in the treatment of schizophrenia.
According to an application submitted by researchers from the Mount Sinai School of Medicine in New York to the World Health Organisation (WHO) in January 2013, risperidone is among the most commonly prescribed atypical antipsychotic drugs in the U.S., and in 2008, it was used for specific indications in over 12 million outpatient visits.
The shares of Cadila Healthcare Ltd stood at Rs 334 at 2:14 p.m. Tuesday on the BSE, down Rs 4.15 or 1.23 percent, after the drug recall from U.S. market.