Product: Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Reason for recall: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Recall initiated: 20200107
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated