# FDA recall D-0197-2024

> **CARDINAL HEALTHCARE** · Class II · drug recall initiated 2022-01-26.

## Product

SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA.  NDC: 0597-0075-41

## Reason for recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0197-2024
- **Recalling firm:** CARDINAL HEALTHCARE
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-26
- **Report date:** 2024-01-03
- **Termination date:** 2024-09-29

- **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-0197-2024

## Citation

> AI Analytics. FDA recall D-0197-2024. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0197-2024. Source: US FDA. Licensed CC0.

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