Ranitidine — Class II drug recall D-0793-2020
Terminated recall by H J Harkins Company Inc dba Pharma Pac, reported 2020-01-29, distributed in CA, FL, NC, SC. CGMP Deviations: Presence of NDMA impurity detected in product.
| Recall number | D-0793-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | H J Harkins Company Inc dba Pharma Pac, Grover Beach, CA, United States |
| Recall initiated | 2020-01-06 |
| Classified | 2020-01-20 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2023-12-15 |
| Distributed | CA, FL, NC, SC |
| Quantity | 7,212 tablets |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30, 52959-0502-60 |
| Lot numbers | 05/20, 05/21, 10/20, 11/20, RAN63KG, RAN64KG, RAN65KG, RAN66KG |
Product
Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60
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-0793-2020. 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.