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Metformin batch recalled due to contamination with possible carcinogen

2020-11-03T21:02:40.279Z


Tests on the drug - which helps lower blood glucose levels - revealed levels of nitrosamine, or NDMA, above acceptable limits in the recalled tablets.


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(CNN) -

Two batches of metformin, a widely used type 2 diabetes drug, are being recalled due to possible contamination with a potentially carcinogenic compound.

Metformin is designed to lower glucose levels.

Nostrum Laboratories Inc., based in Kansas City, Missouri, announced Monday that it would voluntarily recall its extended-release metformin HCl tablets, USP 750 mg, as announced by the US Food and Drug Administration, FDA.

Testing revealed levels of nitrosamine, or NDMA, above acceptable limits in the recalled tablets.

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The chemical NDMA is considered a possible carcinogen by the US Environmental Protection Agency (EPA).

It is an organic chemical used to make liquid rocket fuel and can be a by-product of manufacturing, including pharmaceutical manufacturing.

It is also found in water and food, including meats, dairy, and vegetables.

NDMA has also been found in certain blood pressure medications and antacids.

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This is the latest in a series of metformin recalls.

All have been linked to potentially carcinogenic contaminants in drugs.

Nostrum said it has not received any reports of adverse events related to the recall.

The company also said it was notifying its distributors and arranging for the return of the recalled product.

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The impacted product is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01.

Affected metformin HCl extended release tablets, USP 750 mg batches are under NDC 29033-056-01, batch numbers MET200101 and MET200301 with expiration date 05/2022.

It can be identified as an oblong off-white tablet with the inscription 'NM7'.

More than 34 million people in the United States have diabetes, about 1 in 10, and about 90 to 95% of them are diagnosed with type 2 diabetes, according to the US Centers for Disease Control and Prevention. , CDC.

- CNN's Hollie Silverman contributed to this report.

Metformin

Source: cnnespanol

All news articles on 2020-11-03

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