# FDA recall D-0895-2022

> **Direct Rx** · Class II · drug recall initiated 2022-05-11.

## Product

Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

## Reason for recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

## Distribution

FL

## Key facts

- **Recall number:** D-0895-2022
- **Recalling firm:** Direct Rx
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-11
- **Report date:** 2022-06-01
- **Termination date:** 2022-12-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dawsonville, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0895-2022

## Citation

> AI Analytics. FDA recall D-0895-2022. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0895-2022. Source: US FDA. Licensed CC0.

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