D-1013-2020 Class II Terminated
FDA drug recall D-1013-2020 was initiated by Perrigo Company PLC on October 23, 2019 and is designated Class II. Reason for recall: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. The recall status is terminated (terminated November 6, 2020).
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
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;
Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Distribution Pattern
Nationwide USA
Code Information
Lots: 8DE1367, 8EE1559, 8FE1451, 8GE1340, 8HE1222, 8KE2831, 8JE1917, 8KE2245 , 8ME2724, 9AE2831, 9DE2747, 9CE3339, 9EE2636, 9FE2971, 9GE2793, 9GE3220