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Antidiabetic drugs have been recalled because they contain high levels of carcinogens

 


The widely used diabetes drug was recalled after the manufacturer discovered that it contained unacceptably high levels of carcinogenic contaminants. Indian pharmaceutical company Marksans Pharma Limited is recalling metformin hydrochloride sustained release tablets due to levels of NDMA, which is “probably a human carcinogen.” According to a recall released this week by the Food and Drug Administration, it exceeded the acceptable daily intake limit of 96 nanograms. Metformin tablets are used in the treatment of type 2 diabetes and are designed to lower glucose levels. The recall applies to metformin. Time-Cap Labs, Inc. 500 mg to 750 mg tablets sold under the brand name of. The recall extends the previous recall of the same product from this summer. However, this is just one of several metformin products that were found to contain NDMA last year. Seven other pharmaceutical companies have issued recalls of metformin hydrochloride sustained-release tablets for their carcinogenic content. Video above: Living with Type II Diabetes The FDA is still investigating where NDMA comes from and how it is included in metformin products. Most levels found in medicines are generally low, within the FDA’s approved daily intake range, but recently recalled medicines exceed that. However, Marksans Pharma Limited of India has not disclosed the amount of NDMA contained in the recalled product. The recall applies to the following products: These products can be identified by the country drug code number listed below (you can search and identify using the country drug code). Products online through the FDA). The tablets are 101 or 102 embossed on one side and plain on the other side. Metformin Hydrochloride Sustained Release Tablets, USP 500mg: 90 Counts: 49483-623-09100 Counts: 49483-623-01500 Counts: 49483-623-50 1000 Counts: 49483-623-10 Metformin Hydrochloride Sustained Release Tablets, USP 750mg: 100 Count: 49483-624-01

The widely used antidiabetic drug was recalled after the manufacturer discovered that it contained unacceptably high levels of carcinogenic contaminants.

Indian pharmaceutical company Marksans Pharma Limited is recalling metformin hydrochloride sustained release tablets. This is because the level of “potentially carcinogenic to humans” NDMA was higher than the acceptable daily intake of 96 nanograms. Recall announced by the Food and Drug Administration this week..

Metformin tablets are used to treat type 2 diabetes and are designed to lower blood sugar levels.

Recalls are Time-Cap Labs, Inc. Applies to 500 mg to 750 mg metformin tablets sold under the brand name of.

The recall extends the previous recall of the same product from this summer. However, this is just one of several metformin products that were found to contain NDMA last year. Seven other pharmaceutical companies have issued recalls of metformin hydrochloride sustained-release tablets due to their carcinogenic content.

Video above: Life with type II diabetes

FDA Still investigating where NDMA came from And how does it end up in metformin products? Most levels found in medicines are generally low, within the FDA’s approved daily intake range, but recently recalled medicines exceed that. However, India’s Marksans Pharma Limited did not reveal the amount of NDMA contained in the recalled product.

The recall applies to the following products: National drug code The numbers listed below (you can use the National Drug Codes to search and identify products online through the FDA). The tablet is 101 or 102 embossed on one side and plain on the other.

Metformin Hydrochloride Sustained Release Tablets, USP 500mg:

90 counts: 49483-623-09

100 counts: 49483-623-01

500 counts: 49483-623-50

1000 counts: 49483-623-10

Metformin Hydrochloride Sustained Release Tablets, USP 750mg:

100 counts: 49483-624-01

..

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