Drug major Sun Pharma is recalling over ten lakh boxes of its anti-allergic Loratadine drug from the US market 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".
Comments from the company could not be obtained immediately.
Loratadine is an antihistamine and is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose.
Shares of Sun Pharma today ended at Rs 901 apiece on the BSE, down 0.49 per cent from previous close.