FDA Drug recall D-1025-2020
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75
- FDA Drug
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75 by Perrigo, citing CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1025-2020 |
| 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
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
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Identifiers
| code_info | Lots:8EE1514, 8EE1515, 8FE1353, 8GE1732, 8GE1864, 8HE1652, 8HE1653, 8JE2235, 8KE2724, 8KE2725, 8LE2…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 |
|---|
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-1025-2020%22
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