# FDA recall D-1230-2014

> **Boehringer Ingelheim Roxane Inc** · Class III · drug recall initiated 2014-03-27.

## Product

Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany.

## Reason for recall

Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1230-2014
- **Recalling firm:** Boehringer Ingelheim Roxane Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-03-27
- **Report date:** 2014-04-16
- **Termination date:** 2015-01-26

- **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-1230-2014

## Citation

> AI Analytics. FDA recall D-1230-2014. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1230-2014. Source: US FDA. Licensed CC0.

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