FDA Drug recall D-1028-2020
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82
- 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, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82 by Perrigo, citing CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1028-2020 |
| 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, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82
Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Identifiers
| code_info | Lots: 8AE1291, 8AE1785, 8BE1415, 8CE1525, 8DE1201, 8DE1741, 8EE1323, 8FE1806, 8GE1965, 8HE1517, 8JE…Lots: 8AE1291, 8AE1785, 8BE1415, 8CE1525, 8DE1201, 8DE1741, 8EE1323, 8FE1806, 8GE1965, 8HE1517, 8JE2161, 8KE2565, 8LE2261, 8ME2548, 9AE2658, 9BE3018, 9CE3861, 9DE3244, 9FE2820, 9FE3373, 9GE3094, 9HE3449, 9JE2665 |
|---|
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-1028-2020%22
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