Is there a recall on metformin
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Recall on Metformin Due to Nitrosamine Impurities
Detection of NDMA in Metformin Products
Recent recalls of metformin, a widely used anti-diabetic medication, have been prompted by the detection of N-nitrosodimethylamine (NDMA), a potentially carcinogenic impurity. Regulatory bodies have identified NDMA levels above the acceptable intake limit of 96 ng per day in some batches of metformin products. This impurity is of significant concern due to its genotoxic and carcinogenic potential .
International Regulatory Actions and Findings
An international regulatory collaboration has been actively monitoring metformin for nitrosamine impurities. Between November 2019 and July 2020, 1090 samples of metformin, including both active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs), were tested. NDMA was detected in 17.8% of the FDF samples, while 82.2% of the samples met safety standards. This extensive testing underscores the ongoing efforts to ensure the safety of metformin products.
Specific Recalls and Affected Batches
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) recalled a specific batch of Rosemont Pharmaceuticals' metformin oral solution due to NDMA levels exceeding the acceptable limit. The affected batch (0LL0018) was distributed in December 2020, and healthcare professionals were advised to stop supplying this batch and return any remaining stock. This recall was a precautionary measure, as long-term exposure to NDMA, even at low levels, poses a potential health risk.
Root Causes of NDMA Formation
Research has identified several factors contributing to the formation of NDMA during the manufacturing of metformin tablets. Key factors include the use of water and heat during intra-granulation and the presence of nitrite/nitrate in excipients. Specific excipients, such as hydroxypropyl methylcellulose (HPMC) and carboxymethyl cellulose sodium, were found to contribute to NDMA formation when combined with water and heat. Understanding these root causes is crucial for developing strategies to mitigate NDMA contamination in future batches.
Regulatory Guidelines and Future Directions
The FDA and other regulatory agencies have issued guidelines to control nitrosamine impurities in drug products. These guidelines emphasize the importance of adhering to regulatory standards and employing approved manufacturing technologies to prevent contamination . Ongoing collaboration between regulatory bodies and pharmaceutical companies aims to identify and address the root causes of nitrosamine formation, ensuring the continued safety and efficacy of metformin .
Conclusion
The detection of NDMA in some batches of metformin has led to recalls and heightened regulatory scrutiny. While the majority of metformin products remain safe, ongoing efforts to understand and mitigate the formation of nitrosamine impurities are essential. Regulatory agencies and pharmaceutical manufacturers must continue to work together to ensure the safety of this critical medication for patients with type 2 diabetes.
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