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Aurobindo Pharma recalls 2352 bottles of Simvastatin tablets over labelling issue

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Aurobindo Pharma recalls 2352 bottles of Simvastatin tablets over labelling issue

The reason for the recall of lipid-lowering Simvastatin tablets is “Labeling; incorrect or missing lot and/or exp date; some bottles labelled with lot number 05318054B instead of 05318034B,” Aurobindo Pharma added.

New Delhi: 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 in its Enforcement Report.

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The voluntary ongoing nationwide recall is a class III recall, it added.

Read Also: Aurobindo Pharma, Shanghai LongJin sign deal to form JV in China

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The product was distributed nationwide by three major distributors who may have further distributed the product, the report said.

The reason for the recall is “Labeling; incorrect or missing lot and/or exp date; some bottles labelled 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”.

Read Also: 2 dead, 1 injured after fire engulfed Aurobindo Pharma power plant in Andhra Pradesh


Source: PTI
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