Drug firm Sandoz Inc is recalling India-made 1,023,430 units of anti-allergic Cetirizine HCl chewable tablets in the US due to impurity concerns.
According to information on the 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 Sandoz Private Ltd 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 United States Food and Drug Administration (USFDA) said in an Enforcement Report for the week of June 10, 2015.
A Class III recall is initiated in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Sandoz is the generic pharmaceuticals division of drug major Novartis.