Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Recall Number: D-0792-2020
Firm: Mylan Pharmaceuticals Inc.
Classification: Class II
Status: Terminated
Report Date: 20200129
Initiation Date: 20200107
Termination Date: 20210519
Reason for Recall
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Product Description
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.