FDA Drug recall D-1013-2020
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2
- FDA Drug
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2 by Perrigo, citing CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1013-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-23 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Perrigo |
| Distribution | US |
Product
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
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Identifiers
| code_info | Lots: 8DE1367, 8EE1559, 8FE1451, 8GE1340, 8HE1222, 8KE2831, 8JE1917, 8KE2245 , 8ME2724, 9AE2831, 9DE…Lots: 8DE1367, 8EE1559, 8FE1451, 8GE1340, 8HE1222, 8KE2831, 8JE1917, 8KE2245 , 8ME2724, 9AE2831, 9DE2747, 9CE3339, 9EE2636, 9FE2971, 9GE2793, 9GE3220 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1013-2020%22
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