Product: Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
Reason for recall: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated: 20191023
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated