# FDA recall D-901-2013

> **AbbVie Inc.** · Class III · drug recall initiated 2013-08-01.

## Product

Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only,  Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA

## Reason for recall

Labeling: Incorrect Package Insert; product packaged with outdated version of the insert

## Distribution

Nationwide

## Key facts

- **Recall number:** D-901-2013
- **Recalling firm:** AbbVie Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-01
- **Report date:** 2013-08-28
- **Termination date:** 2013-11-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-901-2013

## Citation

> AI Analytics. FDA recall D-901-2013. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-901-2013. Source: US FDA. Licensed CC0.

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