The US arm of drug major Aurobindo Pharma is recalling 2,352 bottles of lipid-lowering Simvastatin tablets from the American market, the latest enforcement report of the US health regulator said.
Aurobindo Pharma USA Inc is recalling 2,352/1,000 count bottles of Simvastatin tablets USP 40 mg manufactured by Aurolife Pharma LLC, the United States Food and Drug Administration (USFDA) said its Enforcement Report.
The voluntary ongoing nationwide recall is a class III recall, it added.
The product was distributed nationwide by three major distributors who may have further distributed the product, the report said.
The reason for recall is "Labeling; incorrect or missing lot and/or exp date; some bottles labeled with lot number 05318054B instead of 05318034B," it 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".