Sun Pharma recalls anti-allergic drug from US market

Sun Pharmaceuticals has initiated a recall of over million boxes of anti-allergic Loratadine drug from the US market after checks revealed the tablets were 'super potent' and 'out of specification.'

Loratadine tablets are manufactured and distributed in the US market by Ohm Laboratories, a New Jersey-based subsidiary of Ranbaxy. Loratadine is generic version of Bayer's Claritin drug.

Sun Pharma acquired Ranbaxy in a $4 billion deal in 2014 making it the largest Indian pharma company by sales. US contributes to a half of its revenue but its sales in the market have been impacted following US Food and Drug Administration imposed restrictions on production facilities in India.

In the Q1 US sales were down 4 percent due to temporary supply constraints arising out of Halol plant.

Sun Pharma did not comment on the recall initiated by Ohm Laboratories. Sources said it was a voluntary recall initiated by the company and said it was classified as a Class III recall action which meant the use of or exposure to a violative product is unlikely to cause adverse health consequences.