# FDA recall D-0431-2021

> **Cardinal Health Inc.** · Class II · drug recall initiated 2021-03-15.

## Product

edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 60631-425-30 Manufactured for Arbor Pharmaceuticals Atlanta, GA 30328

## Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

## Distribution

FL, GA, SC

## Key facts

- **Recall number:** D-0431-2021
- **Recalling firm:** Cardinal Health Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-15
- **Report date:** 2021-06-02
- **Termination date:** 2024-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0431-2021

## Citation

> AI Analytics. FDA recall D-0431-2021. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/D-0431-2021. Source: US FDA. Licensed CC0.

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