Related Drugs: Glucophage XR, Metformin / Pioglitazone, Pioglitazone/Metformin, Metformin Hydrochloride (glumetza), Vildagliptin/Metformin Hcl, Kombiglyze XR, Metformin XR, Janumet XR, Metformin SR, Glumetza, Metformin (Glucophage)
The U.S. Food and Drug Administration (FDA) has announced that they discovered a nitrosamine impurity N-Nitrosodimethylamine (NDMA) which exceeded the acceptable limit in tested lots of Metformin extended-release. The FDA has reached out to five firms to recommend a voluntary recall. Stay updated on FDA recalls here. According to the FDA “patients should continue taking metformin tablets even after recalls occur, until they consult with their health care professional who can prescribe a replacement.”Health Canada, the UK Medical Health Products Regulatory, and the European Medicines Agency Administration have previously provided information on NDMA impurities with metformin. You can stay updated below:
The U.S.
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Laws affecting the importation of medication for personal use are different from country to country. For instance, personal drug importation is expressly legal in Australia. In the United States, technically, it is illegal to import unapproved medication under most circumstances, whether through purchase over the Internet or while on a trip to a foreign country. U.S. government officials have stated that individuals who order non-controlled prescription drugs from foreign sources (up to a three-month supply) for their own use are not being pursued or prosecuted. The U.S FDA regulates the safety and efficacy of medications sold in U.S. pharmacies. Medications dispensed from outside the U.S. are regulated for safety and efficacy by pharmaceutical/pharmacy regulatory authorities in their respective countries. Read about Advanced Pharmaceutical Regulatory Systems.
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