Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets — Class II drug recall D-0093-2019
Terminated recall by RemedyRepack Inc., reported 2018-10-31, distributed in SC. CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceu
| Recall number | D-0093-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2018-08-24 |
| Classified | 2018-10-24 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2018-10-29 |
| Distributed | SC |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 13668-0325-30, 70518-1220-00 |
| Lot numbers | 70518-1220-00, B0438903-052118 |
Product
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
Reason for recall
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
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-0093-2019. 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.