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Notes
NDMA = N-nitrosodimethylamine
GERD = gastroesophageal reflux disease
Reference
US Food and Drug Administration. Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited. Internet Document : 8 Jan 2020. Available from: URL: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-three-lots-nizatidine-capsules-usp-due-detection-trace
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Mylan voluntarily recalls nizatidine capsules due to NDMA impurity. Reactions Weekly 1787, 1 (2020). https://doi.org/10.1007/s40278-020-73639-1
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DOI: https://doi.org/10.1007/s40278-020-73639-1