Unichem Lab recalls 368 bottles of anti-epileptic drug in US

New Delhi: Drug firm Unichem Laboratories is recalling 368 bottles of Lamotrigine tablets, used for treating epilepsy and bipolar disorder, in the US due to “incorrect imprint debossed on the tablets”.  The recall has been initiated by the company’s US arm Unichem Pharmaceuticals Inc covering 368 bottles of Lamotrigine tablets USP in strength of 150 mg, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report. The tablets have been manufactured at the company’s Goa facility. A single bottle contains 500 tablets of the medicine. Citing reasons for the recall, the USFDA said: “Incorrect imprint debossed on the tablets”. The recall is a ‘Class III recall’, the US health regulator added. As per the USFDA, 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.” Unichem initiated the recall on August 19 this year. Comments from the company could not be immediately obtained. Unichem shares today ended at Rs 282.60 apiece on the BSE, down 1.41 per cent from previous close.