# FDA recall D-126-2013

> **Boehringer Ingelheim Roxane Inc** · Class III · drug recall initiated 2012-12-12.

## Product

Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.

## Reason for recall

Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-126-2013
- **Recalling firm:** Boehringer Ingelheim Roxane Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-12-12
- **Report date:** 2013-01-23
- **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-126-2013

## Citation

> AI Analytics. FDA recall D-126-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-126-2013. Source: US FDA. Licensed CC0.

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