The company said that it is voluntarily recalling lots of Risperidone 2 mg and 4 mg, 60-count bottles due to out of specification results observed during stability testing.
"We have already put into place a corrective action plan to address the event, which we believe is isolated to these lots,' the company spokesperson said.
Currently, Risperidone 2 mg and 4 mg represent approximately 0.1 per cent of total North America Generic sales. Risperidone is an antipsychotic medication and is used to treat schizophrenia and symptoms of bipolar disorder (manic depression).
It is also used in autistic children to treat symptoms of irritability. The company said it believed that the recall will not have a material impact on the business.
As an organisation, it continues to operate and take actions in the best interest of patients.