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 (FDA) 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 US drug regulator said: "Incorrect imprint debossed on the tablets."
The recall is a 'Class III recall', it added.
According to the FDA, 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.
Shares in Unichem, on Wednesday, ended 1.41 per cent lower at Rs 282.60 apiece on the BSE, whose benchmark Sensex finished down 0.40 per cent.
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