Sandoz Recalls One Million Units of CetirizineBy
Sandoz has issued a Class III voluntarily recall for the antihistamine,cetirizine HCl chewable tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. The product was manufactured by Sandoz Private Limited in Mumbai, India for Sandoz Private Limited in Princeton, New Jersey. The recall involves 1,023,430 units for failed impurities/degradation specifications: an out-of- specification result was reported for impurity at the 21-month stability time point.
The recall was initiated on April 15, 2015, and reported in the US Food and Drug Adminstration’s weekly Enforcement Report of June 10, 2015. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.