Lupin Ltd. and Cadila Healthcare Ltd.'s units initiated a voluntary recall of 111,648 units of duloxetine 30 mg delayed-release capsules and 19,812 bottles of paroxetine 30mg tablets from the U.S. market, respectively.
According to an enforcement report by the U.S. Food and Drug Administration, Lupin Pharmaceuticals Inc.'s class III recall for duloxetine was due to "failed dissolution specification" and Zydus Pharmaceuticals (USA) Inc.'s class II recall of paroxetine was due to the presence of foreign tablets/capsules as risperidone tablets were found in a bottle of paroxetine tablets.
