3 FDA recalls mention Nizatidine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Nizatidine.
Reason CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Reason CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Reason CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
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