Metformin recall
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Some studies suggest metformin products generally meet quality and safety standards, while other studies indicate recalls due to nitrosamine impurities above acceptable limits.
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Metformin Recall Due to Nitrosamine Contamination
Introduction to Metformin Recalls
Metformin, a widely used medication for managing type 2 diabetes, has recently been subject to recalls due to contamination with N-nitrosodimethylamine (NDMA), a potentially carcinogenic impurity. This article synthesizes the findings from multiple studies and regulatory reports to provide a comprehensive overview of the issue.
Detection of NDMA in Metformin
International Regulatory Collaboration
An international regulatory laboratory network has been actively monitoring metformin for nitrosamine impurities. Between November 2019 and July 2020, 1090 samples of metformin, including 875 finished dosage forms (FDFs) and 215 active pharmaceutical ingredient (API) samples, were tested. NDMA was detected in some batches of metformin products, with 17.8% of FDF samples containing NDMA above the acceptable intake (AI) level of 96 ng per day. However, 82.2% of the samples met quality and safety standards.
Specific Batch Recalls
The UK Medicines and Healthcare products Regulatory Agency (MHRA) recalled a specific batch of Rosement Pharmaceuticals' metformin oral solution due to NDMA levels exceeding the acceptable limit. The batch in question, Metformin Hydrochloride 500mg/5ml Oral Solution (batch number 0LL0018), was first distributed in December 2020. The recall was a precautionary measure, and patients were advised to continue taking their medication while seeking advice from healthcare professionals.
Implications for Patient Safety
Potential Health Risks
NDMA is classified as a probable human carcinogen, meaning it has the potential to cause cancer if consumed over long periods. Regulatory agencies emphasize that the detected levels of NDMA in metformin are low and pose a minimal risk to patients. However, the presence of this impurity necessitates ongoing monitoring and corrective actions to ensure patient safety .
Regulatory Actions and Recommendations
Regulatory agencies are collaborating with marketing authorization holders to identify the root causes of NDMA formation in metformin and to implement corrective measures. This includes improving manufacturing processes and enhancing quality control to prevent future contamination.
Conclusion
The detection of NDMA in some batches of metformin has led to recalls and increased scrutiny from regulatory agencies. While the majority of metformin samples tested met safety standards, the presence of this impurity highlights the need for continued vigilance and regulatory oversight to ensure the safety of this essential medication. Patients are advised to follow guidance from healthcare professionals and regulatory bodies regarding the use of metformin.
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