Over ten lakh boxes of anti-allergic Loratadine drug has been recalled from the US market by Sun Pharmaceuticals as the lot was found to be 'super potent' and 'out of specification'.
As per the information available on the USFDA website, Ohm Laboratories Inc, a unit of Ranbaxy Laboratories, which the company acquired last year, is recalling 10,85,095 boxes for being "Superpotent Drug: Out Of Specification".
Sun Pharma had acquired Ranbaxy in a USD 4 billion deal last year making it the largest Indian pharma company by sales.
The recall was initiated on July 28 this year and has been put under Class-III which FDA defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences".
Loratadine is an antihistamine and is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose.