Losartan HCTZ 50/12 — Class II drug recall D-0885-2022
Terminated recall by RemedyRepack Inc., reported 2022-06-01, distributed in FL. CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
| Recall number | D-0885-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2022-05-04 |
| Classified | 2022-05-20 |
| Reported by FDA | 2022-06-01 |
| Terminated | 2022-09-02 |
| Distributed | FL |
| Quantity | 22 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 33342-0050-10, 70518-3231-00 |
| Lot numbers | B1377711-100521, B1412137-102621 |
| Expiration dates | 2022-10-31 |
Product
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
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-0885-2022. 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.