New Delhi: The US health regulator’s latest enforcement report said that 2352 bottles of lipid-lowering Simvastatin tablets are being recalled by the US arm of drug major Aurobindo Pharma from the American market.
Its Enforcement Report said that 2,352/1,000 count bottles of Simvastatin tablets USP 40 mg manufactured by USFDA (the United States Food and Drug Administration), Aurolife Pharma LLC are being recalled by Aurobindo pharma Usa Inc.
It added that the ongoing, voluntary nationwide recall is a class III recall.
The report said that three major distributors distributed the product nationwide, who may have further distributed the product.
It additionally said that the recalling was done due to incorrect or missing lot and/or exp date: Labeling. Also, some bottles, instead of being labeled of 05318034B, were labeled with lot number 05318054B
In a situation “in which use of or exposure to a violative product is not likely to cause adverse health consequences”, a class III recalled is initiated according to the USFDA.