Ranitidine 150 mg — Class II drug recall D-0016-2021
Terminated recall by Direct Rx, reported 2020-10-14, distributed in FL, GA. CGMP Deviations: Presence of NDMA impurity detected in product.
| Recall number | D-0016-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2020-01-15 |
| Classified | 2020-10-05 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2020-12-07 |
| Distributed | FL, GA |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 61919-0339-60, 61919-0339-90 |
| Expiration dates | 2022-02-28, 2022-03-31 |
Product
Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
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-0016-2021. 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.