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Nostrum Laboratories Extended-release Metformin Recalled Due to N- nitrosodimethylamine (NDMA) Contamination

Posted: November 14, 2020 According to cardiovascularbusiness.com[1], the FDA[2] announced one more recall of extended-release (ER) metformin. Nostrum Laboratories’ metformin was recalled due to an unacceptable level of N-nitrosodimethylamine (NDMA). N-nitrosodimethylamine (NDMA) is a known carcinogen. Nostrum Laboratories, a medication manufacturer, based in Kansas City, Missouri, announced the recall this week. Nostrum Laboratories is recalling two lots of their ER metformin tablets. According...

MasterPharm, LLC — Problems With More Recalled Compounded Drugs

Pharmaceutical production isometric flowchart from research tests manufacturing medicine packaging On July 2, 2020, MasterPharm, LLC, a compounding pharmacy based in South Richmond Hill, New York, announced the recall of various lots of numerous drugs compounded and distributed by the pharmacy. The recall includes compounded formulations of: Calcium citrate tetrahydrate USP powder D-Biotin Estriol Finasteride Plus[1] Formula 82F (combination of...

How Does the FDA Handle Prescription Drug Recalls?

When you turn on the TV at night, chances are you will see one or more commercials discussing the recall of a prescription drug. While most people may ignore these commercials, the reality is that prescription drug recalls are not uncommon. However, many people are unaware of the actual drug recall process. It is important to understand why a medication...

Experts Demand Recall For Diabetes Drug Metformin

One of the world’s most popular drugs, Metformin, has been added to a growing list of drugs[1] that contain unacceptably high levels of the cancer-causing chemical N-nitrosodimethylamine (NDMA). On May 28, 2020, a U.S. Food and Drug Administration press release announced that an agency laboratory revealed significant levels of nitrosamine impurity NDMA. This contamination makes thousands of people eligible to...