The US arm of domestic drug major Sun Pharma is recalling over 13,000 bottles of antihistamine, Children's Cetirizine Hydrochloride chewable tablets, from the American market for failed specifications.
Sun Pharmaceutical Industries Inc is recalling 13,200 bottles of the tablets in the strength of 5 mg made at Halol plant, USFDA said in its latest Enforcement Report.
The ongoing class III recall is nationwide in the USA and Puerto Rico, report added.
The reason for the recall is "failed tablet/capsule specifications: out of specification results for increased tablet hardness", United States Food and Drug Administration (USFDA) said.
As per the US health regulator, 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".