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Regulatory updates following recall of valsartan medicines

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Notes

  1. NDEA = N-nitrosodiethylamine

  2. NDMA = N-nitrosodimethylamine

  3. Also see Reactions 1711 p2; 803335025, see Reactions 1716 p1; 803342063 and see Reactions 1717 p3; 803343140

References

  1. US Food and Drug Administration. FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm's already recalled products. Internet Document : 13 Sep 2018. Available from: URL: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620499.htm

  2. European Medicines Agency. Update on review of valsartan medicines. Internet Document : 13 Sep 2018. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/09/news_detail_003015.jsp&mid=WC0b01ac058004d5c1

  3. Government of Canada. Health Canada advises of a second impurity linked to recalled valsartan drugs. Internet Document : 13 Sep 2018. Available from: URL: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67746a-eng.php

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Regulatory updates following recall of valsartan medicines. Reactions Weekly 1721, 3 (2018). https://doi.org/10.1007/s40278-018-52040-2

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