Sandoz recalls its drug in the US
12 June 2015 | News | By BioSpectrum Bureau
Sandoz recalls its drug in the US
The tablets were manufactured by the company's unit in Navi Mumbai
Sandoz Inc, the generic pharmaceuticals division of drug major Novartis is recalling 1,023,430 units of anti-allergic Cetirizine HCl chewable tablets in the US due to impurity concerns.
According to information on the United States Food and Drug Administration (USFDA) site, the recall is for Cetirizine HCl chewable tablets of 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations.
The tablets were manufactured by the company's unit in Navi Mumbai.
The firm-initiated Class III recall is due to "failed impurities/degradation specifications after an out of specification ( OOS) result was reported for impurity at the 21 month stability time point," the USFDA said in an Enforcement Report for the week of June 10, 2015.
