Was metformin recalled and why
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Metformin Recall Due to NDMA Contamination
Introduction to Metformin Recalls
Metformin, a widely used medication for managing type 2 diabetes, has faced recalls in various regions due to contamination concerns. The primary reason for these recalls is the detection of N-nitrosodimethylamine (NDMA), a potentially carcinogenic impurity, in some batches of the drug.
Detection of NDMA in Metformin
International Regulatory Actions
International regulatory bodies have been actively monitoring metformin for nitrosamine impurities, particularly NDMA. A comprehensive analysis of 1090 samples, including both active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs), revealed that 17.8% of the FDF samples contained NDMA levels above the acceptable intake (AI) limit of 96 ng per day. This led to the recall of certain batches to ensure patient safety.
Specific Recalls
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) recalled a batch of Rosemont Pharmaceuticals' metformin oral solution due to NDMA levels exceeding the acceptable limit. The recall was a precautionary measure, as NDMA is known to be potentially genotoxic and carcinogenic. Despite the recall, patients were advised to continue taking their medication and consult healthcare professionals for further guidance.
Root Causes of NDMA Formation
Manufacturing Process Factors
Research has identified several factors contributing to NDMA formation during the manufacturing of metformin tablets. Key contributors include the use of water and heat during intra-granulation, as well as the nitrite and nitrate content in excipients. Specific excipients like polyvinyl pyrrolidone and hydroxypropyl cellulose were found to prevent NDMA formation even when water and heat were used. This understanding is crucial for developing strategies to mitigate NDMA contamination in future production.
Regulatory and Industry Response
FDA Guidelines and Industry Measures
The FDA has issued guidance to the pharmaceutical industry to control nitrosamine impurities in drug products. This guidance followed the recall of over 1400 product lots, including metformin, due to unacceptable levels of carcinogenic N-nitrosamines. Regulatory agencies continue to collaborate with manufacturers to identify the root causes of NDMA formation and implement corrective actions to ensure the safety and quality of metformin products.
Conclusion
The recall of metformin due to NDMA contamination highlights the importance of stringent quality control and regulatory oversight in the pharmaceutical industry. Ongoing research and collaboration between regulatory bodies and manufacturers are essential to prevent such issues and ensure the safety of medications for patients.
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