Diabetes Drug Metformin Hydrochloride Recalled Over Possible Cancer-Causing Ingredient
Metformin Hydrochloride, a drug prescribed to diabetic patients, has been recalled over the concerns that it might contain a large amount of cancer-causing ingredients.
This week, it was announced by the Food and Drug Administration (FDA) that a popular drug Metformin Hydrochloride contains an unusual amount of N-Nitrosodimethylamine (NDMA), a human carcinogen.
The manufacturer of Metformin, Marksans Pharma Limited, expanded a recall which was initially announced in June. The recall now includes additional 76 unexpired lots of medications, as per The Sun.
Metformin Hydrochloride is marketed as "extended-release tablets" under Time-Cap Labs. Inc. brand name. The drug helps lowering the blood sugar levels of those with type 2 diabetes. The recall applies to metformin tablets between 500mg-750mg.
According to CNN, the FDA investigation is ongoing where the NDMA came from and how metformin products contained it. Most levels of NDMA were found in drugs that are generally low and fall within the FDA's approved daily intake.
"Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day," the FDA statement reads.
The statement continued and said that it could be harmful to patients with type 2 diabetes to stop their metformin intake without talking first to their health care experts. That's why users are advised to continue taking the recalled tablets up until a medical expert provides an alternative or replacement treatment option.
For an added safety caution, the recall had an additional 76 lots, the agency added. On one side, the 500mg metformin tablets are embellished with "101" while the 750mg metformin tablets are debossed with "102" on one side.
If consumers have experienced any problems related to taking or using metformin hydrochloride, they should contact their physician as soon as possible, as per the IB Times.
The affected Metformin Hydrochloride was packed in high-density polyethylene bottles in 1,000, 500, 100, and 90 counts.
The 500mg and 750mg Metformin tablets are white to off-white in color and are capsule-shaped biconvex tablets. Click here to see the full list of the recalled Metformin tablets and medication labels. Consumers who have recalled Metformin medication should return it to where they purchased it. For questions and inquiries about the recall.
You may direct to Irene McGregor, vice-president of regulatory affairs at Time-Cap Labs, dial 1-631-753-9090 from Monday to Friday, 8 AM to 5 PM EDT. You may also send your queries through email at firstname.lastname@example.org.
Meanwhile, Marksans Pharma Limited said it didn't receive any reports of adverse reactions from the recalled drug.
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