As per the information available on the USFDA website, drug giant t Sun Pharma is recalling 10,85,095 boxes of its anti-allergic drug Loratadine from the US market, for being "Super potent Drug: Out Of Specification".
Loratadine is an antihistamine and is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose.
Ohm Laboratories Inc, a unit of Ranbaxy Laboratories, which the company acquired last year, 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.
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