Sun Pharmaceutical Industries Ltd.'s U.S. arm is recalling 13,200 bottles of children's cetirizine hydrochloride chewable tablets from the U.S. and Puerto Rico markets, according to an enforcement report by the U.S. FDA.
The ongoing class III recall by Sun Pharmaceutical Industries Inc. is for the 5 mg tablets, made at the company's Halol plant in Gujarat, India, because of failed tablet/capsule specifications.
The tablets are used for preventing or treating certain symptoms of hay fever and other upper respiratory allergies.