# FDA recall D-0885-2022

> **RemedyRepack Inc.** · Class II · drug recall initiated 2022-05-04.

## 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

## Distribution

Recalled product was distributed to Florida.

## Key facts

- **Recall number:** D-0885-2022
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-04
- **Report date:** 2022-06-01
- **Termination date:** 2022-09-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indiana, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0885-2022

## Citation

> AI Analytics. FDA recall D-0885-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0885-2022. Source: US FDA. Licensed CC0.

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