Micro Labs is voluntarily recalling 54,096 bottles of Simvastatin Tablets, a drug for lowering cholesterol, in the US market for failing to meet specifications.
As per the information available on the US Food and Drug Administration website, Micro Labs USA is recalling certain lots of the drug in various strengths--20 mg, 40 mg and 80 mg, for "failed impurities/degradation specifications".
The company is recalling 27,144 of 20 mg tablets, 13,488 bottles of 40 mg tablets and 13,464 bottles of 80 mg tablets in the American market, the US health regulator added.
The recall was initiated by the company on December 4, 2014. It has been classified as a 'Class-III recall' under which FDA defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences".
The drug was manufactured by the Bangalore-based firm at its Goa facility and distributed by Micro Labs USA Inc.
An email query sent to Micro Labs remained unanswered.
