FDA Drug recall D-1027-2020
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01
- 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, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01 by Perrigo, citing CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1027-2020 |
| 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, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01
Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Identifiers
| code_info | Lots: 8BE1032, 8BE1486, 8CE1638, 8DE1361, 8DE1612, 8FE1354, 8GE1737, 8HE1654, 8JE2237, 8KE2726, 8LE…Lots: 8BE1032, 8BE1486, 8CE1638, 8DE1361, 8DE1612, 8FE1354, 8GE1737, 8HE1654, 8JE2237, 8KE2726, 8LE2369, 8ME2645, 9AE2777, 9CE3315, 9DE2720, 9EE2578, 9FE2956, 9GE2698, 9GE3202 |
|---|
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-1027-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.