The Nostrum Laboratory Laboratory Inc. announced from Kansas City, Missouri, the voluntary withdrawal of its prolonged liberation tablets HCL metformin, USP 750 mg.This was announced by the US Food and Medicines Administration, FDA, since the medicine has a content of n-nitrosodimethylamine (NDMA) above the acceptable daily intake limit (ADI).
Throughout the country, the retirement of two lots of metformin will be made, a medication used for type 2 diabetes. According to the FDA, the medicine could be contaminated by the presence of the NDMA, classified as a substance that could cause cancer.The indications were made after the medicine was subjected to laboratory tests, which indicated that it contains more of the substance than the body is able to process.
The voluntary withdrawal occurred despite the fact that there have been no reports of adverse effects to metformin.However, the measure was taken because the medication is widely used to control type diabetes, specifically to reduce glucose levels.
The FDA asked consumers to communicate with their doctor or medical care provider if they have experienced any problem that may be related to the intake of this medicine.
What is the NDMA present in medicine for retired diabetes?
The NDMA, explained the FDA, "is a known environmental pollutant and is found in water and food, including meats, dairy products and vegetables."
This chemist was classified as a potential causing cancer.It is usually used to make fluid fuel for rockets.
On other occasions, NDMA has been found in drugs for blood pressure and antacids.
The retired product is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01.The prolonged liberation tablets of affected HCL metformin, 750 mg lots of USP are under NDC 29033-056-01, lot numbers Met200101 and Met200301 with expiration date 05/2022.Consumers who have it can identify them as an oblong tablet of whitish color with the registration "NM7".