# FDA recall D-067-2013

> **Boehringer Ingelheim Roxane Inc** · Class II · drug recall initiated 2012-11-05.

## Product

Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54

## Reason for recall

Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product

## Distribution

Nationwide

## Key facts

- **Recall number:** D-067-2013
- **Recalling firm:** Boehringer Ingelheim Roxane Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-11-05
- **Report date:** 2012-12-05
- **Termination date:** 2013-09-18

- **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-067-2013

## Citation

> AI Analytics. FDA recall D-067-2013. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-067-2013. Source: US FDA. Licensed CC0.

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