# FDA recall D-1057-2013

> **Boehringer Ingelheim Roxane Inc** · Class III · drug recall initiated 2013-08-30.

## Product

SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany

## Reason for recall

Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1057-2013
- **Recalling firm:** Boehringer Ingelheim Roxane Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-30
- **Report date:** 2013-09-25
- **Termination date:** 2014-06-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1057-2013

## Citation

> AI Analytics. FDA recall D-1057-2013. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1057-2013. Source: US FDA. Licensed CC0.

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