There have been voluntary recalls of metoprolol products in the United States. These recalls were typically initiated due to the presence of unacceptable levels of nitrosamine impurities, specifically N-nitrosodimethylamine (NDMA) [1]. Nitrosamines are common substances that can be found in water and certain foods, but some nitrosamines have been found to cause cancer in laboratory animals [2].
Why were metoprolol products recalled?
The voluntary recalls were prompted by the detection of NDMA in metoprolol products that exceeded the acceptable daily intake levels. The Food and Drug Administration (FDA) has set interim guidelines for nitrosamine impurity levels, and when a product's impurity level surpasses this threshold, a recall is typically initiated by the manufacturer [2].
Which metoprolol products have been recalled?
Recalls have affected various metoprolol products, including metoprolol tartrate tablets. For example, Teva Pharmaceuticals issued a voluntary recall of certain lots of metoprolol tartrate tablets USP in 2020 due to NDMA impurities [1].
What is NDMA and why is it a concern?
N-nitrosodimethylamine (NDMA) is a probable human carcinogen. While trace amounts of nitrosamines can be found in the environment, elevated levels are a concern for public health. The FDA has been investigating the presence of nitrosamines in drugs since 2019, and this has led to recalls across various drug classes [2].
Who is responsible for drug recalls?
Drug recalls are typically initiated by the drug manufacturer. They are responsible for notifying the public and the FDA about the issue and for retrieving the affected products from the market [1]. The FDA oversees these recalls to ensure they are conducted properly and effectively.
Where can I find information on drug recalls?
Information on drug recalls, including those for metoprolol, can be found on the U.S. Food and Drug Administration (FDA) website. The FDA maintains a database of enforcement reports that include details about ongoing recalls [1]. You can also consult resources like DrugPatentWatch.com for information on drug-related issues [1].