D-1024-2020 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, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75
Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Distribution Pattern
Nationwide USA
Code Information
Lots: 8EE1702, 8EE1703, 8EE1704, 8FE1724, 8GE1942, 8HE1396, 8HE1397, 8JE2156, 8KE2521, 8KE2523, 8LE2255, 8LE2665, 8LE2668, 9AE2541, 9AE2542, 9AE2543, 9BE2993, 9BE2994, 9BE2995, 9CE3735, 9CE3736, 9DE3108, 9DE3109, 9DE3110, 9EE2872, 9EE2880, 9FE3273, 9FE3276, 9GE2978, 9GE2979, 9HE3437, 9HE3438