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 company has initiated the recall on August 19 this year.
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 tablets have been manufactured at the company’s Goa facility. A single bottle contains 500 tablets of the medicine.
The recall is a ‘Class III recall’ and as per the US Food and Drug Administration (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 Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world. In India, the company is a leader in niche therapy areas of cardiology, neurology, orthopedics and anti-infectives.
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