# FDA recall D-0971-2022

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

## Product

Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90

## Reason for recall

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

## Distribution

AL, GA, FL, LA

## Key facts

- **Recall number:** D-0971-2022
- **Recalling firm:** Direct Rx
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-05
- **Report date:** 2022-06-08
- **Termination date:** 2023-10-05

- **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-0971-2022

## Citation

> AI Analytics. FDA recall D-0971-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0971-2022. Source: US FDA. Licensed CC0.

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