Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy… — Class II drug recall D-0798-2020
Terminated recall by RemedyRepack Inc., reported 2020-01-29, distributed in CA, NY. CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above establis
| Recall number | D-0798-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2019-12-11 |
| Classified | 2020-01-20 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2020-07-23 |
| Distributed | CA, NY |
| Quantity | 4,486 tablets |
| Reason classes | chemical contamination, cgmp |
| NDC | 65162-0253-10, 70518-1714-00 |
| Lot numbers | J0349352-012519, J0376034-052319, J038005-082719, J0390277-072519, J0390280-072519, J0406133-093019 |
| Expiration dates | 2020-01, 2020-05, 2020-07, 2020-08, 2020-10 |
Product
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Reason for recall
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0798-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.