Metformin recall list
Searched over 200M research papers
Summary
3 papers analyzed
These studies suggest a batch of metformin was recalled due to nitrosamine impurity, while most metformin products met safety standards despite some concerns.
Not a yes or no question
To use the Consensus Meter, try asking a simple yes or no question
Research summarized with Copilot
Beta20 papers analyzed
Metformin Recall List: Key Insights and Regulatory Actions
Nitrosamine Impurities in Metformin
Detection of NDMA in Metformin Batches
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recalled a specific batch of Rosemont Pharmaceuticals’ metformin oral solution due to the detection of N-nitrosodimethylamine (NDMA), a nitrosamine impurity, above acceptable limits. The batch in question is Metformin Hydrochloride 500mg/5ml Oral Solution, batch number 0LL0018, with an expiry date of November 2021. This recall is a precautionary measure as NDMA is potentially genotoxic and carcinogenic.
International Regulatory Collaboration
An international regulatory laboratory network has been actively monitoring metformin-containing medicines for nitrosamine impurities. From November 2019 to July 2020, 1090 samples of metformin active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs) were tested. NDMA was detected in some batches, with 17.8% of the FDF samples containing NDMA above the acceptable intake (AI) level of 96 ng per day. However, 82.2% of the samples met the quality and safety standards.
Regulatory Actions and Recommendations
MHRA's Precautionary Measures
The MHRA has advised healthcare professionals to stop supplying the affected batch and return any remaining stock to the supplier. Patients who have this batch at home should continue taking their medication but consult their doctor or pharmacist for further advice. The marketing authorization holder has placed all remaining stock of metformin oral solution on hold while investigating NDMA levels.
Ongoing International Efforts
Regulatory agencies worldwide continue to collaborate extensively to understand the root causes of nitrosamine formation in metformin and to implement corrective actions. This collaboration aims to mitigate the presence of NDMA in future batches of metformin, ensuring patient safety and maintaining drug quality.
Conclusion
The detection of NDMA in certain batches of metformin has led to recalls and increased regulatory scrutiny. While the presence of NDMA is concerning, the majority of metformin samples tested have met safety standards. Ongoing international collaboration and regulatory actions are crucial in addressing this issue and ensuring the continued safety of metformin for patients.
Sources and full results
Most relevant research papers on this topic
