Metaformin recall
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Some studies suggest metformin has been recalled due to nitrosamine impurities, while other studies indicate it generally meets quality and safety standards.
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Metformin Recall Due to Nitrosamine Impurities
Introduction to Metformin Recalls
Metformin, a widely used medication for managing type 2 diabetes, has recently been subject to recalls due to the detection of nitrosamine impurities, specifically N-nitrosodimethylamine (NDMA). NDMA is a potential carcinogen, and its presence in pharmaceuticals has raised significant safety concerns.
Detection of NDMA in Metformin
International Regulatory Collaboration
An international regulatory laboratory network has been actively monitoring metformin for nitrosamine impurities. This collaboration involved testing 1090 samples of metformin, including both active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs). The results showed that NDMA was detected in some batches of metformin products, with 17.8% of FDF samples containing NDMA levels above the acceptable intake (AI) limit of 96 ng per day. However, 82.2% of the samples met the quality and safety standards.
Specific Recalls
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) recalled a batch of Rosement Pharmaceuticals’ metformin oral solution due to NDMA levels exceeding the acceptable limit. The recall was a precautionary measure, and patients were advised to continue taking their medication while seeking advice from healthcare professionals.
Regulatory Actions and Safety Measures
FDA Guidance and Industry Response
The FDA has issued guidance to the pharmaceutical industry to control nitrosamine impurities in drug products. This guidance came after the detection of unacceptable levels of nitrosamines in various medications, including metformin. The FDA's database indicates that over 1400 product lots have been recalled due to nitrosamine contamination.
Ongoing Investigations
Regulatory agencies continue to work with marketing authorization holders to understand the root causes of nitrosamine formation and to implement corrective actions. This ongoing collaboration aims to mitigate the presence of NDMA in future batches of metformin.
Conclusion
The detection of NDMA in metformin has led to significant regulatory actions, including recalls and the implementation of stricter controls on nitrosamine impurities. While the presence of NDMA in some batches of metformin is concerning, the majority of tested samples have met safety standards. Ongoing efforts by regulatory agencies and the pharmaceutical industry are crucial to ensuring the safety and efficacy of metformin for patients.
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