D-1025-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 25, 2020
- Initiation Date
- October 23, 2019
- Termination Date
- November 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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.
Distribution Pattern
Nationwide USA
Code Information
Lots:8EE1514, 8EE1515, 8FE1353, 8GE1732, 8GE1864, 8HE1652, 8HE1653, 8JE2235, 8KE2724, 8KE2725, 8LE2367, 8ME2643, 8ME2644, 9AE2766, 9AE2767, 9CE3273, 9CE3274, 9DE2629, 9DE2630, 9EE2516, 9EE2517, 9FE2915, 9FE2916, 9GE2694, 9GE3144